Regulatory Affairs Professional

Vor 4 Tagen

Burgenland, Österreich Life Science Recruitment Vollzeit

Job Title: Senior Regulatory Affairs Specialist – Post market

Location: Galway, Ireland. Flexible working arrangement available.

Overview:

Life Science Recruitment is a leading provider of recruitment services to the life sciences industry. We are currently seeking an experienced Senior Regulatory Affairs Specialist to join our client's team in Galway, Ireland.

Responsibilities:

  • Implement post-market activities as identified under Post Market Regulatory Reporting and change assessment.
  • Approve Vigilance/MDR reporting as defined in each territory.
  • Support and lead Regulatory Post Market System improvements.
  • Participate in the implementation of Field Safety Corrective Action plan and associated activities if required.
  • Manage RA activities for Design Changes and Supplier-related changes including reporting assessment and generation of regulatory submissions.
  • Provide RA Support to relevant Design Teams for Key Projects identified by Veryan.
  • Provide support to other RA Specialists in achieving success for the team.
  • Manage and support trend data for regulatory reporting.
  • Management of PMA Annual Periodic Reporting system and approval of annual documentation for submission to FDA.
  • Manage post-market scheduling of RA activities for timely completion and submission to regulatory authorities.
  • Review and approval of RA QMS procedures and work instructions and ensure activities are performed in line with these.

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