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Job Description
Role:
Regulatory Specialist (Post-Market Surveillance)
Location:
Annacotty, Limerick
Main Duties:
- Coordination & Planning: Oversee Post Market Surveillance (PMS) and Post Market Performance Followup (PMPF) activities and reporting.
- Liaison: Collaborate with departments on PMS and PMPF requirements.
- Regulatory Reporting: Handle complaints, CAPAs, and nonconformances for CE-IVD products.
- Vigilance Activities: Manage Manufacturer Incident Reporting, Regulatory Body correspondence, and recalls/mock recalls.
- Regulatory Files: Review and maintain Regulatory files for distribution.
- Technical Documentation: Update Design History Files/Technical Files/Risk documentation with postmarket data.
- Artwork Review: Ensure compliance of labels and instructions with regulatory requirements and international standards.
- Change Controls: Assess impact on regulatory compliance.
- Legislation Monitoring: Track changes in legislation and standards, and communicate findings to teams.
Essential Criteria:
- Experience: Minimum 2 years in a PMS/Vigilance role in Medical Devices or In Vitro Diagnostics.
- Education: BSc in Biomedical Science/Engineering or related field.
- Standards Knowledge: Familiarity with ISO 13485 and ISO 1497
- Skills: Ability to meet tight deadlines, good initiative, and team player.
- License: Full clean driver's license.
Desirable Criteria:
- Technical Files: Experience with medical device technical file preparation and maintenance.
- Directive Experience: Knowledge of MDD/MDR and/or IVDD/IVDR.
- QMS & Audits: Experience with QMS and product audits from Notified Bodies.