Regulatory Affairs Specialist

22 hours ago


Edinburgh, Edinburgh, United Kingdom Cpl Healthcare Full time

About the Role

As a Regulatory Affairs Specialist, you will play a crucial part in maintaining product and site regulatory & quality compliance to ensure license/registration is maintained once granted. This role reports to the Chief Regulatory Affairs and Quality Officer and oversees end-to-end regulatory packages under ODM-Distributor schemes, ensuring compliance with established quality management systems.

Main Responsibilities:

  1. Preparing Regulatory Documentation: Coordinate and execute 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 as necessary.
  2. Advising on Regulatory Requirements: Advise staff and project team members on data and information required for successful license applications, ensuring their contributions are produced to an appropriate standard for submission.
  3. Quality Assurance Release: Ensure Quality Assurance release of incoming goods, intermediate, and final product obligations for AliveDx Suisse SA.
  4. Point of Contact: Be a point of contact for regulatory & quality compliance issues.
  5. Reporting Incidents: Interface with Competent Authorities for reporting incidents and field safety actions, including FSCA, FSN, recalls, and MDRs (medical device reporting).
  6. Supporting QMS Organization: Support QMS organization during regulatory inspections or certifications audits.
  7. Compliance with Company Standards: Conduct all duties in compliance with company Quality Management System and cGMP, GCP, and ISO13485 requirements.

Requirements:

  • Masters degree or equivalent in life sciences and 3-5 years of experience in a regulatory/quality role.
  • Experience in medical device / IVD / biotech industry.
  • Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics.

About You

We are seeking a highly experienced Regulatory Affairs Specialist to join our team at Cpl Healthcare. The ideal candidate will have a strong understanding of regulations applicable to medical devices and a proven track record of ensuring compliance with established quality management systems.

Salary: Up to £50,000 + Benefits



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