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Senior Regulatory Affairs Manager

3 weeks ago

Galway, Galway, Ireland beBeeRegulatory Full time €60,000 - €85,000
We are seeking a highly skilled Regulatory Affairs Specialist to join our company at Veryan Medical. This is an exciting opportunity to play a key role in the implementation of post-market activities and contribute to the future success of our business.

Key Responsibilities:
  • Implementation of Post Market Surveillance activities under Post Market Regulatory Reporting and change assessment as defined in Quality System procedures and Work Instructions.
  • Approval of Vigilance/MDR reporting for each territory.
  • Support and lead Regulatory Post Market System improvements.
  • Participation in Field Safety Corrective Action plan and associated activities if required.
  • Management of RA activities for Design Changes and Supplier-related changes, including reporting assessment and generation of regulatory submissions.
  • RA Support to relevant Design Teams for Key Projects identified by Veryan Medical.
  • Support to other RA Specialists in achieving team success.
  • Management and support of trend data for regulatory reporting.
  • Support of Gap Assessment process and associated process improvements.
  • Management of PMA Annual Periodic Reporting system and approval of annual documentation for submission to FDA.
  • Post-market scheduling of RA activities for timely completion and submission to regulatory authorities.
  • Review and approval of RA QMS procedures and work instructions.
  • Implementation of Technical File for updates arising from changes.
  • Identification and awareness of new regulation requirements or changes required to be considered by Veryan Medical for regulatory compliance in all territories for post-market activities.

Requirements:

  • A degree level qualification in Engineering, Science, QA, or related field is essential.
  • A minimum of five years experience at a senior regulatory level in the medical device industry is essential.
  • A minimum of five years' experience in the creation of regulatory submissions for premarket approval is required.
  • Experience of FDA guidance for sterile implantable products in premarket approvals is desirable.
  • Technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and the FDA QSRs is a prerequisite.