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 driver’s 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
Skills:
Regulatory Compliance, Post-Market Surveillance and Vigilance Expertise, Technical Documentation Management
Benefits:
Work From Home
