Regulatory Compliance Specialist

3 hours ago


Edinburgh, Edinburgh, United Kingdom SRG Full time
Regulatory Compliance Officer

SRG is seeking a highly skilled Regulatory Compliance Officer to join their team in Edinburgh. As a key member of the team, you will be responsible for delivering end-to-end regulatory packages under the ODM-Distributor scheme, ensuring compliance with quality management systems.

Key Responsibilities:
  • Prepare and compile regulatory documentation, coordinating and executing regulatory submissions in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Medical Device Approvals (510(k)), and other country requirements.
  • Advise staff and project team members on data and information required for successful license applications, ensuring their contributions to regulatory applications meet submission standards.
  • Ensure Quality Assurance release of incoming goods, intermediate, and final product obligations.
  • Act as a point of contact for regulatory and quality compliance issues.
  • Interface with Competent Authorities for reporting incidents, field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
  • Support QMS organisation during regulatory inspections or certifications audits.
  • Conduct all duties in compliance with company Quality Management System and cGMP, GCP, and ISO13485 requirements.
Requirements:
  • Scientific degree.
  • Extensive 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.).
  • Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics.
Benefits:
  • Private Medical cover.
  • Life assurance.
  • Additional annual leave.
  • Cycle to work scheme + more.


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