Role: Regulatory Specialist (Post-Market Surveillance)
Location: Annacotty, Limerick
Main Duties:
* Coordination & Planning: Oversee Post Market Surveillance (PMS) and Post Market Performance Follow-up (PMPF) activities and reporting.
* Liaison: Collaborate with departments on PMS and PMPF requirements.
* Regulatory Reporting: Handle complaints, CAPAs, and non-conformances 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 post-market 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 14971.
* 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.
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