Job Description
Overview: Our client, a global leader in diagnostics based in Limerick, is seeking a Regulatory Specialist (Post-Market Surveillance) to join their team in a full-time, permanent hybrid role. This innovative company is at the forefront of healthcare solutions, and the successful candidate will oversee PMS activities, regulatory compliance, and vigilance reporting. Regulatory Specialist (Post-Market Surveillance) Full time, permanent hybrid position - Hybrid after 3 months Reporting to: Regulatory Manager Responsibilities: 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 the company's 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 If you are living in Ireland and hold a VALID WORK PERMIT, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search. Skills: Regulatory Compliance Post-Market Surveillance and Vigilance Expert Technical Documentation Management Benefits: Work From Home