Job Description
Regulatory Specialist(Post-Market Surveillance) Full time, permanent position Reporting to the Regulatory Manager Main Duties: 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 Serosep products and present findings to cross functional teams, as required. Essential Criteria: Min 2 years experience in a PMS/Vigilence 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 and team player Full clean drivers licence Desirable Criteria: 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 Closing Date: 24th September 2024