- Reference: GJ42833
- Job Type: Permanent
- Location: Galway
- Category: Science, Pharmaceutical & Food
The sucessful candidate will become part of the Company – a multinational medical devices organisation who are setting up operations in Galway, Ireland for their European Operations.
- Manage, lead and build the regulatory function for Europe.
- Overall responsibility for organisation Regulatory /QA Functional requirements and compliance.
- Actively address and ensure compliance with the requirements of FDA, CMDCAS, EU Medical Device Directive (CE mark and US FDA experience for class III medical devices including ISO 13485, 14971, 25539, 10993 and 11135 – compliance)
- Provide technical expertise and ownership responsibility for currency of device Technical Files and Design Dossiers.
- Support Europe and Corporate RA Groups in product registration documentation submittals, including support of Manager regarding issue of document notarization / authentication.
- Maintenance of Product Licences and expediting renewal or upgrading of same.
- Perform and maintain Risk Assessments on product and processes, per ISO 14971, leading the Team in successful completion of same.
- Actively participate in review activities of the Engineering change function, assuring changes are risk assessed, and provide sign-off on regulatory and all labeling changes.
- Support D-FMEA and P-FMEA process on established, proposed changes to or new processes, mitigating risk and controlling compliance to Risk Management and cGMP requirements.
- Conduct Internal QMS Audits with focus on regulatory compliance.
- Direct liaison with Competent Authorities, (IMB) and Product Safety Inspectors (i.e. UL) on product registrations and in facilitating of site inspections.
- Provide Promotional literature review (PMAP) to assure compliance with stated data to regulatory and product specific requirements.
- Perform duty of Medical Specialist for products, assessing complaints/incidents to determine if they are considered reportable to relevant authorities. Ensure good root cause analysis and risk mitigation performed, to effect timely closure of reportable events.
- Obtain and evaluate PMS data, ensuring impacted files are updated accordingly, and any process or product changes necessary are effectively processed through the change system.
- Monitor trends in compliance market, updates to regulations, emerging standards and guidelines, providing effective and meaningful training and interpretive guidance to the functional group on regulatory policies, procedures.
- Work closely with Quality Manager to effect roll-out of Quality / Regulatory Initiatives and Corporate SOPs.
- Provide RA and compliance expertise during any BSI or FDA Inspections.
- Interpret regulations, provide regulatory guidance; Serving as internal expert on regulatory issues.
- Perform other duties as may be assigned in support of compliance.
Skills, Experience and Qualifications:
- Primary Degree in Engineering/ Science
- 3rd level qualification in Quality Assurance would be beneficial.
- Direct experience with CE mark and US FDA experience for class III medical devices including ISO 13485, 14971, 25539, 10993 and 11135.
- 2 -4 years managing regulatory or equivalent staff. Ability to manage a team, recognise the team’s strengths, development needs, and professional goals, and inspire them to succeed
- Minimum of 8 – 10 years’ experience in ISO 13485, CMDCAS and FDA 21CFR820 regulated Medical Device manufacturing company, with Class I thru Class III (EU) and Class II (US) products.
- Successful demonstrable hands-on track record in Regulatory Compliance, including product registrations and submittals.
- Must have audit-facing experience with FDA and EU Competent Authorities
- Experience managing intermediate to small functional group
- High levels of energy, can absorb information with calm, and have excellent skills to analyze & synthesis data.
- Experience in managing complex projects with multiple tasks and shifting priorities.
- Execution – persistent drive for results utilising sound project focus, organisational and problem solving skills.
- Assertive, strong communications skills and Pro-active team player.
For a confidential discussion and more information on the role/company please contact Christopher O’Toole on 091-706713 or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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