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Regulatory Affairs Officer

2 months ago

Greater Edinburgh Area, United Kingdom Cpl Life Sciences Full time

Job Title: Regulatory Affairs Officer

Job Type: Full-time, permanent position

Location: Outskirts of Edinburgh, Scotland, UK - 3x a week on site

Remuneration: £35,000 to £37,000 + benefits

Here's a fantastic opportunity to become part of a well-established and expanding IVD manufacturer and contribute to the growth of the Regulatory Affairs Department. As a Regulatory Affairs Officer, you'll play a key role in developing regulatory strategies, ensuring compliance with relevant regulations, and managing product license registrations globally.

Main responsibilities:

  • Prepare and organize regulatory documentation for submissions complying with various regulations such as ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), and more.
  • Offer guidance to team members on data requirements for license applications and oversee their contributions to regulatory submissions.
  • Define product labeling requirements, including package labels and instructions for use, for both company products and customer-contracted items.
  • Collaborate with internal and external stakeholders to develop product labeling materials.
  • Stay updated on new regulatory requirements, guidance documents, and industry standards to support regulatory compliance.
  • Maintain product regulatory documents and technical files to ensure adherence to various regulations (US, EU, Japan, Brazil, Canada).
  • Support the Department Leader of Regulatory Affairs in coordinating team activities and providing training and supervision to junior staff for their professional development.

Requirements:

  • Relevant degree or work experience in regulatory affairs.
  • Work experience in the medical device / IVD / biotech industry.
  • Specialized knowledge of vigilance processes for different jurisdictions (MDR, BPDR, MEDDEV 2.12, etc.).
  • Previous experience with regulatory submissions like BLA, 510(k), PMA, and CE mark applications.
  • Expertise in engaging with regulators through meetings and presentations.
  • Capability to prepare comprehensive regulatory reports and filings.

This is a fantastic chance to join a leading company in the IVD industry and make a significant impact in the regulatory landscape.

Please note this position does not offer sponsorship.

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