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Regulatory Affairs Specialist

2 months ago

Edinburgh, Edinburgh, United Kingdom Clinical Professionals Limited Full time
Senior Regulatory Compliance Officer – IVDs

Job Type: Contract

Location: Edinburgh

Remuneration: £35,000 – £40,000

Clinical Professionals Limited is seeking a highly skilled Senior Regulatory Compliance Officer – IVDs to join our team. As a key member of our Regulatory Affairs Department, you will be responsible for delivering an end-to-end regulatory package under ODM-Distributor scheme in compliance with established quality management system.

Key Responsibilities:

  1. Preparing and compiling regulatory documentation, coordinating and executing regulatory submission 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 appropriate.
  2. 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.
  3. Ensure Quality Assurance release of incoming goods, intermediate and final product obligations.
  4. Be a point of contact for regulatory & quality compliance issues.
  5. Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
  6. Support QMS organization during regulatory inspections or certification audits.
  7. Conduct all duties in compliance with company Quality Management System and cGMP, GCP and ISO13485 requirements.

Requirements:

  1. Master degree or equivalent in life sciences and 3-5 years of experience in a regulatory/quality role.
  2. Experience in medical device / IVD / biotech industry.
  3. Specific technical competencies required for the role (e.g.: GMP, GLP exposure, FDA exposure, IT packages, technical writing skills).
  4. Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, CMDR, etc.).