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.
