Regulatory Affairs Specialist
1 week ago
SRG is seeking a highly skilled Regulatory Affairs Officer to join their team in Edinburgh. As a key member of the team, you will be responsible for ensuring the company's compliance with regulatory requirements.
Key Responsibilities:- Implement and maintain regulatory compliance processes, including regulatory evaluation of non-conformances and post-market surveillance.
- Act as the main contact for regulatory compliance issues and maintain post-market surveillance processes.
- Provide PMS documentation according to IVDR requirements and lead 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, and BPDR.
- 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 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.
- Experience in meeting with and negotiating with regulators.
- Private Medical cover.
- Life assurance.
- Additional annual leave.
- Cycle to work scheme.
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