Regulatory Officer

Our Client a leading medical device company in Limerick is hiring a full time Regulatory Officer. The successful candidate will report to the Quality Manager.

Responsibilities include but are not limited to the following:

• Coordination and planning of Post Market Surveillance (PMS) activities and reporting, including Post Market Performance Follow up (PMPF).
• Assist in preparation of regulatory submissions for specific target markets for product changes and re-registrations as required.
• Liaise with other departments on the relevant requirements for PMS and PMPF.
• Review and analyse to ensure the outputs meet the applicable regulatory requirements.
• Reviewing complaints, CAPAs and non-conformances for regulatory reporting for CE-IVD marked products.
• Coordination and planning of vigilance activities, including Manufacturer Incident Reporting, correspondence with Regulatory Bodies and recalls/mock recalls, as required.
• Coordinate review of new and maintain existing Regulatory files for distribution business of the organization
• Coordinate update of Design History File/Technical File/Risk documentation with post market data.
• Assist in review and approval of artwork (labels, Instructions for use) for compliance with applicable regulatory requirements and international standards, including UDI.
• Review change controls for impact on regulatory compliance.
• Monitor changes in legislation, standards and guidance documents related to products and present findings to cross functional teams, as required.
  

• Min 2 years’ experience in a Medical Device or an In Vitro Diagnostic Company
• BSc in molecular biology or related discipline
• Working knowledge of ISO 13485 and ISO 14971 standards
• Experience with Post Market Surveillance and Vigilance activities
• Ability to work to tight deadlines
• Good initiative and team player
• Full clean driver’s license
• Desirables: Experience in preparation of medical device technical files and regulatory submissions; MDD/MDR experience and/or IVDD/IVDR experience; Experience with QMS and product audits from Notified Bodies

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

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