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.Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy
