Regulatory Specialist (Post-Market Surveillance)

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.#L1-DB4

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