Regulatory Affairs Specialist

5 days ago


Edinburgh, Edinburgh, United Kingdom SRG Full time

SRG is seeking a highly skilled Regulatory Affairs Specialist to join their team in Edinburgh. The successful candidate will be responsible for implementing and maintaining regulatory compliance processes, including regulatory evaluation of non-conformances, post-market surveillance, vigilance, and associated reporting.

Key Responsibilities:
  • Act as the main contact for regulatory compliance issues
  • Maintain post-market surveillance processes
  • Provide PMS documentation according to IVDR requirements
  • Lead and coordinate the vigilance process in interface with the complaint handling process
  • Interface with Competent Authorities for reporting incidents and field safety actions
  • Evaluate product/process non-conformances and determine whether they need to be reported to the Competent Authorities
  • Support QMS organisation during regulatory inspections or certification audits
  • Liaise with regulatory authorities and external contract bodies
Requirements:
  • Scientific degree
  • Previous regulatory experience within Medical Devices / IVD
  • Experience of working within an FDA licensed manufacturing facility
  • Specialist knowledge of regulations as applied to medical devices, in vitro diagnostic medical devices, or Biologics
  • Experience in meeting with and negotiating with regulators
Benefits:
  • Private Medical cover
  • Life assurance
  • Additional annual leave
  • Cycle to work scheme


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