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.

• 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

• 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

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.

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

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

#

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.