Regulatory Compliance Specialist

1 month ago


Edinburgh, Edinburgh, United Kingdom SRG Full time

SRG, a leading Biotechnology company based in Edinburgh, is seeking a Senior Regulatory Compliance Officer to join their team on a permanent basis. The estimated salary for this role is £55,000-£65,000 per annum.

About the Role

The Senior Regulatory Officer will be responsible for delivering end-to-end regulatory packages under ODM-Distributor schemes in compliance with established quality management systems. Key responsibilities include overseeing initial compilation of design control evidence, supplier management, incoming inspection and product release process, product submission, post-market surveillance, vigilance, and associated reporting.

  • Preparing and compiling regulatory documentation, coordinating and executing regulatory submissions in compliance with ISO 13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Medical Device Approvals (510(k)), and other country requirements as appropriate.
  • Advising staff and project team members on data and information required for successful license applications and coordinating their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
  • Ensuring Quality Assurance release of incoming goods, intermediate, and final product obligations.
  • Serving as a point of contact for regulatory and quality compliance issues.
  • Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (Medical Device Reporting).
  • Supporting QMS organization during regulatory inspections or certifications audits.
  • Conducting all duties in compliance with company Quality Management System and cGMP, GCP, and ISO 13485 requirements.
Requirements

To be considered for this role, applicants must possess a scientific degree and extensive regulatory experience within Medical Devices/IVD. Previous experience working within an FDA-licensed manufacturing facility is also essential. A strong understanding of regulations as applied to medical devices, in vitro diagnostic medical devices, or biologics is required, including knowledge of directives, approvals, and related procedures.



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