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 organization 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 specialized 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
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