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283 Jobs Found 

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Sterile Manufacturing Team Member

Aerie Pharmaceuticals

Ireland, We
18 days ago
Ireland, We
18 days ago
The Sterile Manufacturing Team Member works as part of the Manufacturing Team preparing and operating process and filling equipment within a clean room manufacturing facility. An essential part of this role is ensuring the operation works to the highest Safety and Good Manufacturing Practices (GMP) standards. The role also plays a significant role in ensuring all batch related documentation meets the standards expected for a sterile manufacturing facility.

Essential Duties, Functions and Responsibilities:
  • Prepares the manufacturing equipment and facility for production batches.
  • Manufactures finished product to cGMP standards.
  • Is trained to and follows the manufacturing procedures and systems of work designed to ensure the facility meets its safety, quality, delivery and cost goals
  • Is trained and qualified to work in a grade B cleanroom and maintains this qualification.
  • Participates in bi-annual media fill studies to maintain qualification status.
  • Is diligent in the completion and review of batch and related documentation required to support the manufacturing process.
  • Is disciplined in ensuring personal hygiene at all time, and in following the garbing and hygiene expectations of working in a sterile manufacturing environment.
  • Assists the Quality organisation in In Process Checks and sampling of product and environmental conditions.
  • Follows procedure in the movement of materials in and out of the cleanrooms.
  • Participates in continuous improvement teams and develops improvement ideas.
  • Supports investigations into manufacturing deviations.
  • Takes responsibility for manufacturing equipment and area condition and supports maintenance activity in the manufacturing area.
  • Supports capital projects throughout equipment lifecycle.
  • Supports product or process development projects and associated validation activities.
  • Is always prepared to escalate any safety or quality risk observed.
Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to gender, marital status, family status, age disability, sexual orientation, race, religion or membership of the Traveller community status.

Skills/Knowledge Required: 
  • Knowledge of aseptic manufacturing techniques and procedures.
  • Capable of working with equipment automation systems required to operate those systems.
  • Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently.
  • Strong team player.
  • Good proactive approach & manner.
 
Education Required:
  • Educated to Leaving Certificate Level.
  • Certificate or Diploma Qualification in a GMP or technical subject would be a distinct advantage.
 
Experience Required:
  • At least 4 - 6 years’ experience in a high volume manufacturing environment in Pharmaceuticals, Medical Device or other equivalent industries.
  • Ideally 1-2 years working as a sterile manufacturing operator.
 
Work Environment/Hazards and Physical Demands:
There is high physical demand in this role due to the nature of working, for extended periods, in a grade B cleanroom environment. The successful candidate must also have the flexibility and fitness to work with a complex filling process through glove ports and to garb into grade B attire while minimising microbial risk to the facility.  While performing the duties of this job, the employee is regularly required to use hands to manipulate objects or controls and to sit, talk, see, and hear. 
 
The employee is frequently required to reach with hands and arms, stand, walk, and lift or move up to 5kg.  The employee is occasionally required to crouch. The employee will be expected to wear protective and/or safety equipment as needed.
 
This role is a shift role and the successful candidate will be expected to work the applicable shift pattern.
 
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed above are representative of the knowledge, skills and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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Senior Program Manager - Flexible Location

Medtronic

Ireland
4 days ago
Ireland
4 days ago
Description

MEDTRONIC
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations


OUR PURPOSE
Do meaningful work, make a difference, and improve lives. At our newly created Market Access Strategic Ops PMO in Medtronic, plc, we are committed creating a strong competitive advantage and delivering accelerated growth in key regions such as China.
The Senior Program Manager will be directly involved in supporting complex, global strategic manufacturing projects across our operations network and operating units in support of manufacturing localization and longer-term operations sustainability initiatives in key growth regions.



A DAY IN THE LIFE OF:
• Reporting directly to the Senior Director of Market Access Operations, you will establish and maintain strong cross-functional collaboration with Operations Networks, Operating Units, Regional leadership & Teams.
• Provide strategic and tactical support across all our Operating units to help accelerate manufacturing transfers.
• Facilitate decision making on receiving site facility locations & make-buy decisions.
• Assess interdependent project issues and develop mechanisms for monitoring project progress and for intervention and problem solving.
• Responsible for developing, communicating, and documenting interdependent project strategies and ensuring good decision making across Operations Networks, Operating Units and Regional teams in terms of priorities.
• Provide status updates to key stakeholders and program sponsors & create integrated Program metrics across internal functions
• The role will also have responsibility for ensuring knowledge sharing across Ops network PMO teams to support accelerated manufacturing start-ups & for driving the development of cross functional playbooks to support Market Access initiatives in different Geographies


Qualifications

KEY SKILLS & EXPERIENCE
• Extensive experience leading complex Global Operating projects/programs
• Great Communication Skills (Verbal, Written, and Presentation Skills)
• Strong Financial and Data analysis Acumen



Must Have: Minimum Requirements
• Bachelors Engineering degree required
• Minimum of 10 years of relevant experience running Global cross functional Strategic Ops programs ideally within the Medical Device Industry.


Nice to Have
• Project management training/PMP Certification
• Manufacturing Engineering experience
• Working in a matrixed organization and ability to work well in a cross-cultural team environment
• Business acumen and understanding of operations costs
• Ability to strongly advocate for and represent Operations to a cross functional team related to project and business needs


Medtronic offer a competitive Salary and flexible Benefits Package

EMEA-Ireland
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Senior Supplier Quality Engineer

Sigmar

Galway City, Galway
7 days ago
Galway City, Galway
7 days ago

Our client, a leading medical device company based here in Galway is looking for a Supplier Quality Engineer to join their team on a 12-month contract.

In this role you would be working with external suppliers as well as within a cross functional team to resolve supplier related issues. This person would be a driving continuous improvement while also driving key quality metrics across the Galway location.

Responsibilities.

  • Communicate with management and project team about supplier performance.
  • Support in review of supplier introduction and changes, coordinating activities with suppliers as well as cross functional teams to develop and implement appropriate strategies to qualify and support.
  • Provide expert QE technical direction input to component qualification strategies.
  • Ensure appropriate controls are in place at supplier based on risk associated with product or service.
  • Develop and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure GMP and quality standards are met.
  • Define receiving inspection requirements as required and associated test method validation for all internal test methods.

Experience.

  • Bachelor’s Degree in a relevant technical discipline such as Engineering or Science or another technical field.
  • Minimum 5 years relevant experience.
  • The ideal candidate is a team player with excellent communication skills both verbal and written.
  • Knowledge of regulatory requirements and guidelines including 21 CFR parts 210,211, 21 CFR part 820, ICH requirements and ISO 13485 is an advantage.
  • Previous experience in Supplier Quality would be an advantage.
  • ISO 13485 Lead Auditor Certification would be an advantage.

 

If you would like to discuss this role, reach out to Rebecca O'Connor on 091 749265 or email 

roconnor@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

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Senior Engineering Manager

Medtronic

Ireland
30+ days ago
Ireland
30+ days ago
Description
FURTHER, TOGETHER
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations.
OUR PURPOSE
At our Research & Development Department in Medtronic, plc, we focus on the development of cutting edge medical devices in the Cardiac and Vascular space. Our Engineers are directly involved in the development of innovative products for use in medical procedures. The Senior R&D Manager is directly involved in providing high level leadership and direction to a diverse R&D team ensuring the implementation of strategic and tactical R&D activities.
The CVG Division has a unique opportunity for the right candidate to take their place amongst the leadership team and help shape the direction of modern interventional treatment within one of the fastest growing businesses in medical devices, an are in which Medtronic is a market leader. You will have the opportunity to guide engineering innovation at the forefront of interventional treatment, developing never before seen devices and more.

Careers that Change Lives
A Day in the Life


Responsibilities may include the following and other duties may be assigned.

  • Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
  • May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
  • Oversees the investigation and evaluation of existing technologies.
  • Guides the conceptualization of new methodologies, materials, machines, processes or products.
  • Directs the development of new concepts from initial design to market release.
  • Manages feasibility studies of the design to determine if capable of functioning as intended.
  • Monitors documentation maintenance throughout all phases of research and development.
  • Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
  • Selects, develops and evaluates personnel to ensure the efficient operation of the function.

Qualifications
Must Have: Minimum Requirements
• We are looking for a qualified person to Level 8 Degree in Engineering / Science or related discipline, Masters preferred and desirably with 10 years relevant direct engineering experience within medical device environment.
• A minimum of three to five years direct managerial experience of engineers and a career history of demonstrated progressive management experience.
• Dynamic team player and leader and can work effectively and proactively on cross-functional teams.
• Experienced in a medical device market and have a proven result driven track record.
• Excellent team building, communication, people management and leadership skills are desirable.
• Good communicator and fluent in English, both in writing and speaking.
Nice to Have
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
EMEA-Ireland
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MDR/Vigilance Specialist

HRM Recruit

Galway, Galway
21 days ago
Galway, Galway
21 days ago

Our client is a global leader in the Medical Devices industry sector. They have undergone significant growth in the past year, and are seeking an experienced MDR/Vigilance Specialist to join the team at their state-of-the-art facility in Galway on a 12 month contract basis. Fully remote working options are available.
The Role
Duties and responsibilities of the MDR/Vigilance Specialist will include but are not limited to:
  • Oversight of complaint handling activities for a wide range of products
  • Overseeing secondary approval of regulatory reporting decisions
  • Timely submission of US Medical Device Report (MDR) and EU Vigilance Reports to external regulatory agencies
  • Support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports
  • Support complaint trend analysis and annual post market surveillance reports for various products
  • Support risk management, risk analysis and health hazard analysis associated with complaint/post-market information
  • Contribute to continuous improvement activities
  • Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies
  • Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements

The Person
You will have skills and experience in the following:
  • BSc and 2+ years of relevant industry experience
  • Candidates with a clinical/medical background will also be considered (e.g. registered nurse or experience in physiological or clinical measurement science)
  • Experience/understanding of complaint handling or CAPA processes are desirable
  • Audit experience desirable
  • Must be a dynamic team player who can work effectively and proactively on cross-functional teams
  • Must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.
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Quality Systems Compliance Specialist

Sigmar

Connacht, Galway
17 days ago
Connacht, Galway
17 days ago

Quality Systems Compliance Specialist

The role requires a minimum of 3 years quality management systems experience in the medical device industry and the candidate must exhibit excellent problem solving and an innovative rational mindset to ensure implementation of advanced, efficient appropriate quality management practices.

Responsibilities:

  • Support and coordinate improvement programs including conducting CAPA analysis to determine root cause and complete problem resolution
  • Coordinate the internal audit program and ensure that Internal Audits are completed
  • Support the preparation and conduct of External Audits
  • Support compliance and continuous improvement QMS related projects
  • Support interactions with certification bodies in relation to QMS auditing, certification, and changes.
  • Support processes for monitoring and measurement of processes including generation of routine QMS performance reports, objectives and KPIs

Experience:

  • Minimum 5 years’ experience in a relevant role in the medical device industry
  • Degree in Quality Assurance, Quality Engineering or similar qualifications
  • Broad experience of Medical Device Quality Management Systems,
  • Experience in CAPA system management,
  • Experience in Complaint handling systems,
  • A working knowledge of FDA requirements and managing regulatory body audits,
  • Proven ability of working in a cross-functional team environment,
  • Knowledge and practical experience with the use of statistical techniques,
  • Training and experience in auditing (internal auditing, supplier auditing or similar),
  • Detail oriented with focus on implementing efficient systems for QMS Compliance.

 

To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

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Planning Manager

Merit Medical

Galway, Galway
30+ days ago
Galway, Galway
30+ days ago
Do you have a proven track record in leading and motivating a team? Are you a natural problem solver with strong organisational skills? If you are a driven, and want to make an impact...this role may be for you ...
The Planning Manager is a key member of the Supply Chain Department who will lead a team of Production Planners who are responsible for planning worldwide supply of material from the Galway Facilities while optimising service and manufacturing efficiencies.
As we continue to grow there is huge opportunity for involvement in streamlining and automating the planning process using our ERP system.
The Role ......
Provides management and direction for the Production Planning process to meet the profitability goals of the division.
Main Duties/Responsibilities:
* Lead the Planning team to ensure they are engaged and high performing with a focus on problem solving and teamwork.
* Perform and manage complex planning projects to build on standardized planning processes, ensure Corporate alignment and inspire a culture of continuous improvement
* Manage S&OP activities that provide analysis which drive business decisions relative to improving service level, manufacturing efficiency and customer service
* Responsible for ERP and system operating parameters to optimize customer service and inventory costs
* Liaise closely with Customer Service to ensure customer orders are delivered on time and queries are responded to in a timely and agreed timeframe.
* Actively ensures that inventory control policy and procedures are being met and that productions planning methods are altered or adapted to meet inventory requirements.
* Leadership responsibilities to include interviewing, hiring, training, performance evaluation, assigning and coordinating work assignments, etc.
* Develop and maintain a positive work climate and the overall team effort of the department.
* Maintain a safe work environment and ensure that employees in area of responsibility are properly trained and follow safety procedures.
* Performs other related tasks, as required.
Qualification/Experiences:
* Education equivalent to a Bachelor's Degree in Logistics, Business or a technical discipline
* A minimum of six years of responsible material's experience to include three years of related people management experience.
* Must have strong interpersonal skills and the ability to work effectively with others as a member of a team.
* Excellent verbal and written communication skills.
* Ability to work as a member of a management team to accomplish organizational objectives and goals.
* Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
* Experience in development and operation of ERP systems. Oracle experience an advantage.
Merit Medical is an Equal Opportunities Employer
#LI-AD1
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At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.
Key Benefits
* Fulltime Permanent contract
* Attractive Salary package
* Defined Contribution Pension Plan
* Health Insurance Cover
* Life assurance
Health & Wellbeing Events Calendar
Excellent career progression opportunities
Recognition scheme
Free Parking
Educational assistance
Internal training courses
Quality Subsidised Canteens & Barista Service
Active Sports and Social Club
We are Global
Merit Medical Galway commenced with 22 employees in 1993. Since then Merit has enjoyed year on year revenue growth and developed its workforce to over 900 employees. Headquartered in Salt Lake City, Utah, Merit maintains a diverse, multi-campus manufacturing footprint in Europe, North America, South America, Asia and Australia with a global distribution.
Medtech Company of the Year Winner
Merit Medical Galway are proud winners of the Medtech Company of the Year Award, a prestigious award recognizing those who are exceling in the MedTech industry
People Development
At Merit Medical Galway almost 60% of all roles are filled by internal employees! We focus on encouraging, believing in and providing a platform for you to progress your career!
Culture
A supportive and collaborative environment make Merit Medical a friendly, enjoyable place to work. We are proud of our energetic and dynamic culture. Diversity & Inclusion is evident here with an 50/50 ratio of male and female employees as well as 30 nationalities onsite! We value every employee as an individual.
To see more on our culture, go to www.merit.com/careers.
Follow Us:
Day in the Life:
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
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Senior Projects Engineer - Production Space Optimisation Job (Galway, G, IE)

Boston Scientific

Galway
9 days ago
Galway
9 days ago

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

About the role:

The purpose of this role is to manage and improve the Production Space Planning process through strong collaboration with each of the production units, the Facilities and Finance departments and to communicate recommendations to the site leadership team. This role will give the ideal candidate a unique opportunity to interact with and influence the senior management and leadership teams in BSC Galway regarding Strategic Space Planning decision making. The role is a stand-alone position that requires the candidate to work on their own initiative and to propose options supporting the campus space strategy. 

This position will report to the site Industrial Engineering and Operations Training Manager.

 

Your responsibilities will include:  

  • Develop and maintain a 5-year Production Space Optimisation plan
  • Responsible for ensuring that all approved moves align to the Production Space Optimisation plan
  • Manage the portfolio of space moves for the campus
  • Initiate or maintain work schedules and priorities for cross departmental space transfers
  • Provide timely communication on project progress to all relevant cross-functional stakeholders, and across all levels of the organization, including the senior leadership team
  • Work with the Industrial Engineering team on the implementation of the Production Space Optimisation plan
  • Identify potential expansion options to meet future business needs for the campus
  • Builds strong relationships and collaborates with Operations, R&D and PD
  • Align closely with Facilities on all planned changes to the plant and off-site locations
  • Support the development of the annual Global Facilities Master Plan (GFMP) for the Galway campus
  • Liaise with finance to establish which projects are tracking to plan and how best to manage financial projections (F1, F2, F3, AOP)
  • Influences, guides, and manages internal/external resources to achieve critical program goals
  • Lead other site/department projects and programs as required
  • Manage all Corporate requests regarding current space utilisation and development plans

What we’re looking for in you:

  • The position requires a bachelor’s degree and experience in high volume manufacturing.
  • BS in Engineering or Science is required at level 8, 240 ETCS credits
  • Must have proven business acumen, effective communication skills, demonstrated track record of project management execution, and leadership experience
  • Engineering background and experience in medical devices industry preferred with exposure to Production Space Planning
  • Demonstrate communication and influencing skills at the highest levels of management across a cross-functional organization.
  • Must have experience managing and leading projects
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Director of Regulatory Affairs, CMEU

Cook Group

Limerick
30+ days ago
Limerick
30+ days ago

Due to a promotion an opportunity has now become available for a Director of Regulatory Affairs CMEU to assume responsibility for CMEU’s regulatory strategy and systems including the EU Authorised Representative (AR) Office.  The EU AR Office is responsible for verifying compliance to the EU MDR on behalf of Cook Medical’s non-EU manufacturers.  The Director of RA acts as the Person Responsible for Regulatory Compliance (PRRC) as per Article 15 of the EU MDR.  The Director of RA is a member of the Location Leadership group.

 

As this role was created as a result of EU MDR, the initial responsibility is to manage and direct the global EU MDR Project to ensure that all Cook Manufacturers are compliant to the new regulations, to enable the EU AR to fulfil its duties.   

 

Reporting to:    Managing Director CMEU/Executive Vice President EMEA with a dotted line to Global Director, Regulatory Affairs


Global MDR Project

Direct and manage the Global MDR Project as follows:

  • Effectively and efficiently schedule all the project activities and timelines to ensure the project objectives are met and delivered within the agreed timeframe.
  • Work with local entities in identifying and resolving resource gaps where necessary. Communicate the plan to local entity leadership teams to ensure buy-in at entity level.   
  • Monitor, track and communicate project progress in a structured and timely manner to Steering committee, Cook Medical Executive team (CME) and key stakeholders.
  • Lead and mentor project teams to ensure that each member understand their role and responsibilities and meets his / her objectives within the scope of the project, escalating issues and take action to address concerns or slippages as appropriate.
  • Anticipate regulatory and other obstacles/ risks and emerging issues throughout the project lifecycle and develop solutions with relevant functions and related teams, taking action as necessary to avoid delays.
  • Be cognisant of departmental expenditure and budget.
  • Meet and engage as directed with regulatory authorities (Competent Authorities, Notified Bodies and global regulatory agencies as required) to understand their needs and expectations.
  • Liaise with Corporate Communications to provide updates across the company.   

Director of RA CMEU

  • Direct, mentor and manage the Regulatory Affairs department ensuring resources and expertise are assigned to meet company goals, objectives and to ensure regulatory compliance.
  • Ensure processes and procedures are put in place as part of the CMEU QMS to carry out the role of EU AR as per Article 11 of EU MDR and per the MDD
  • Fulfil the role of the Person Responsible for Regulatory Compliance (PRRC) as per Article 15 of the EU MDR. Maintain close contact and links with relevant Cook manufacturing sites and ensure contracts / Mandates are in place between the EU AR and Cook manufacturers that the EU AR represents.
  • Liaise with and respond to request for information and/or documentation from Competent Authorities. Inform relevant CA’s of any reportable incidents and field safety corrective actions.
  • Monitor post-market surveillance as necessary.  
  • Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EUMDR 2017/745 and additional EMEA regulations as required.
  • Identify and monitor legislative and regulatory activities, update processes and procedures as appropriate and report their potential impact on the company to local and global leadership as necessary.
  • Provides regulatory support to Cook functional units such as the SSC, tenders, customer quality and distribution partners.
  • Manage regulatory costs and ensure a full understanding of departmental expenditure and budget.
  • Contribute and work as part of the location leadership team to help create a synergistic and cohesive environment. 
  • Ensure compliance to the Quality Management System and Business Processes.

  • A third-level science or engineering degree together with a relevant regulatory science qualification and/or relevant training.
  • 10 years’ experience in a busy regulatory environment with responsibility for multiple medical device classes including class three devices.
  • In-depth knowledge of the EU MDR and its requirements for manufacturers and economic operators.
  • Experience of dealing directly with regulatory authorities such as CA’s, FDA, etc. including submissions, responses to queries, incident reporting and field actions.
  • Proactive and highly motivated; excellent interpersonal and communication skills.
  • Strong organisation skills – ability to prioritise and deal with multiple issues.
  • Flexibility to work outside of normal business hours from time-to-time.
  • Willingness and availability to travel on company business as required – this will include visits to Cook manufacturers as well as meetings with regulatory authorities and participation in Cook RA meetings and inter-functional meetings.

About Cook Medical

Since 1963, Cook Medical has been finding solutions to improve the world’s healthcare problems for the patients and doctors we serve. As one of the world’s largest private companies, we have always operated with our patients, customers, employees and communities at our core. We do this, not only because it is good business, but also because we believe that being a good corporate citizen is the right thing to do.

 

Cook Medical has been in Limerick since 1993. Since opening, we have become a European headquarters for many of Cook’s business functions.

With a global workforce of 12,000, we employ over 850 people in Ireland who bring Endoscopy, Urology and Peripheral Intervention products from conception to commercialisation.

 

Regulatory in Limerick

In Limerick we have more than 35 talented & experienced Regulatory professional working in two distinct Regulatory teams, with Regulatory Global leadership based in Limerick also.

 

Our CMEU regulatory team are responsible for our EU-Rep office. This provides a centralised European office to manage Cook’s responsibilities under EU MDR and ensure a focused and consistent approach to compliance for our medical devices in EMEA. The team are Cook Medicals point of contact for EU regulators. The Cook global implementation for EU MDR is led from this office to ensure that our 8 manufacturing sites globally have a consistent approach to achieving EU MDR compliance in a timely manner.

 

Our CIRL Regulatory team are responsible for global regulation in over 60 countries, managing pre- & post- market regulation for all product classifications and novel devices across EMEA, AMER and APAC. The team works cross functionally with clinical, quality and engineering during the design process and throughout the device lifecycle. The Regulatory Affairs CIRL team are RA are also involved in a broad range of activities including marketing authorization and submissions, vigilance and adverse event reporting and clinical evaluation. 

 

Both of our Regulatory Affairs teams are central to holding Cook to the highest standards because everything we do has an impact on someone’s life.

 

 

Our employee benefits include:

  • Life Assurance and Income Protection cover
  • Educational Assistance
  • Company sponsored Defined Contribution pension scheme
  • Medical Health Insurance cover for you and your immediate family
  • Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks
  • Fully equipped gym on site
  • 39-hour week with flexible start & finish times
  • Paid time off to participate in volunteer activities
  • Free parking
  • Subsidised restaurant
  • Sports & Social club

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Principal Regulatory Affairs Lead

Sigmar

Galway, Galway
18 days ago
Galway, Galway
18 days ago

Principal Regulatory Affairs Lead

Due to continued expansion of our product development portfolio and innovation mandate, we are looking to add an experienced Principal Regulatory Affairs Lead to help drive our regulatory strategy and engage directly with key regulatory bodies across the globe in support of these projects.

Job requirements:

  • Manage regulatory submission timelines, identify risks and appropriate mitigations
  • Review the data intended for submission in international regulatory applications. Identify gaps and make recommendations
  • Support CE Mark maintenance and substantial change submissions to notified body
  • Define and capture the regulatory strategy for the development project(s)
  • Co-ordinate and support regulatory reviews and meetings with EU Notified Bodies, Competent Authorities, FDA, PMDA and NMPA
  • Review and contribute to clinical evaluation reporting activities
  • Support post market surveillance reporting, annual progress reports.

  Experience:

  • Degree level qualification in engineering or a strongly related field
  • A minimum of 5 years’ relevant regulatory experience in a senior regulatory role in the medical device or pharmaceutical industry, ideally with Class IIb and Class III medical devices
  • Technical competency of ISO13485:2016, MDD 93/42/EEC, MDR 2017/745, and the FDA QSRs is a prerequisite
  • Good communication and organizational skills, computer literacy and the ability to present reports neatly and accurately is essential.

 

To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Posted

18 days ago

Description

The Sterile Manufacturing Team Member works as part of the Manufacturing Team preparing and operating process and filling equipment within a clean room manufacturing facility. An essential part of this role is ensuring the operation works to the highest Safety and Good Manufacturing Practices (GMP) standards. The role also plays a significant role in ensuring all batch related documentation meets the standards expected for a sterile manufacturing facility.

Essential Duties, Functions and Responsibilities:
  • Prepares the manufacturing equipment and facility for production batches.
  • Manufactures finished product to cGMP standards.
  • Is trained to and follows the manufacturing procedures and systems of work designed to ensure the facility meets its safety, quality, delivery and cost goals
  • Is trained and qualified to work in a grade B cleanroom and maintains this qualification.
  • Participates in bi-annual media fill studies to maintain qualification status.
  • Is diligent in the completion and review of batch and related documentation required to support the manufacturing process.
  • Is disciplined in ensuring personal hygiene at all time, and in following the garbing and hygiene expectations of working in a sterile manufacturing environment.
  • Assists the Quality organisation in In Process Checks and sampling of product and environmental conditions.
  • Follows procedure in the movement of materials in and out of the cleanrooms.
  • Participates in continuous improvement teams and develops improvement ideas.
  • Supports investigations into manufacturing deviations.
  • Takes responsibility for manufacturing equipment and area condition and supports maintenance activity in the manufacturing area.
  • Supports capital projects throughout equipment lifecycle.
  • Supports product or process development projects and associated validation activities.
  • Is always prepared to escalate any safety or quality risk observed.
Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to gender, marital status, family status, age disability, sexual orientation, race, religion or membership of the Traveller community status.


Skills/Knowledge Required: 
  • Knowledge of aseptic manufacturing techniques and procedures.
  • Capable of working with equipment automation systems required to operate those systems.
  • Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently.
  • Strong team player.
  • Good proactive approach & manner.
 
Education Required:
  • Educated to Leaving Certificate Level.
  • Certificate or Diploma Qualification in a GMP or technical subject would be a distinct advantage.
 
Experience Required:
  • At least 4 - 6 years’ experience in a high volume manufacturing environment in Pharmaceuticals, Medical Device or other equivalent industries.
  • Ideally 1-2 years working as a sterile manufacturing operator.
 
Work Environment/Hazards and Physical Demands:
There is high physical demand in this role due to the nature of working, for extended periods, in a grade B cleanroom environment. The successful candidate must also have the flexibility and fitness to work with a complex filling process through glove ports and to garb into grade B attire while minimising microbial risk to the facility.  While performing the duties of this job, the employee is regularly required to use hands to manipulate objects or controls and to sit, talk, see, and hear. 
 
The employee is frequently required to reach with hands and arms, stand, walk, and lift or move up to 5kg.  The employee is occasionally required to crouch. The employee will be expected to wear protective and/or safety equipment as needed.
 
This role is a shift role and the successful candidate will be expected to work the applicable shift pattern.
 
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed above are representative of the knowledge, skills and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Source: Aerie Pharmaceuticals