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.