Regulatory Specialist

Our Client a leading Medical Device Company in Limerick is hiring a Regulatory Specialist.

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).
  
• Liaise with other departments on the relevant requirements for PMS and PMPF.
• Review 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.
• Coordinate/Update Design History Files/Technical Files/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 PMS/Vigilance role in a Medical Device or an In Vitro Diagnostic Company
• BSc in Biomedical Science/Engineering or related discipline
• Working knowledge of ISO 13485 and ISO 14971 standards
• Ability to work to tight deadlines
• Good initiative, team player & full clean driver’s license

Desirables : Experience in preparation and maintenance of medical device technical files; MDD/MDR experience and/or IVDD/IVDR experience; Experience with QMS and product audits from Notified Bodies

This role will offer great benefits including a hybrid working model to the successful candidate.

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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