Regulatory Compliance Officer (Post Market Surveillance)Location: Edinburgh area - hybrid workingType: 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 issuesMaintain the post market surveillance processesProvide PMS documentation according to IVDR requirementsLead and coordinate the vigilance process in interface with the complaint handling processInterface 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 AuthoritiesSupport QMS organisation during regulatory inspections or certification auditsLiaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised informationContribute to the design and implementation of regulatory processes and identify areas for potential improvementRequirements:Scientific degreePrevious regulatory experience within Medical Devices / IVDExperience 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 regulatorsBenefits:Private Medical coverLife assuranceAdditional annual leaveCycle to work scheme + more.