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Regulatory Compliance Officer

2 months ago

Edinburgh, United Kingdom SRG Full time

Regulatory Compliance Officer (Post Market Surveillance)

Location: Edinburgh area – hybrid working

Type: Full-time, Permanent, 37.5 hours per week.


SRG is working with a leading Biotechnology company based in the Edinburgh area who are looking for a Regulatory affairs officer to join their team on a permanent basis.


The regulatory compliance officer is responsible for implementing and maintaining regulatory compliance processes including regulatory evaluation of non-conformances, post market surveillance, vigilance and associated reporting, regulatory and standard watch.


The Role:

  • Act as the main contact for regulatory compliance issues
  • Maintain the 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, including FSCA, FSN, recalls, MDRs (medical device reporting), BPDR (biological products deviation reports)
  • 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 and, in response to requests from these, to collate and interpret specialised information
  • Contribute to the design and implementation of regulatory processes and identify areas for potential improvement


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 (93/42/EC, 98/79/EC directives, 510(k), PMA, BLA, CMDR, etc.)
  • Experience in meeting with and negotiating with regulators


Benefits:

  • Private Medical cover
  • Life assurance
  • Additional annual leave
  • Cycle to work scheme + more.