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Compliance Officer Full Time Temporary

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.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.

Act as the main contact for regulatory compliance issues
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)
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

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