Regulatory Compliance Officer (Post Market Surveillance)
SRG
Edinburgh, UK
Published 1 week ago
Business Compliance
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:
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
- 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
- Private Medical cover
- Life assurance
- Additional annual leave
- Cycle to work scheme + more.