Regulatory Affairs Officer

6 days ago

Edinburgh, Edinburgh, United Kingdom SRG Full time £40,000 - £65,000 per year

About Our Client:

Our client is a leading organisation in the healthcare and diagnostics sector, committed to delivering innovative solutions and maintaining the highest standards of regulatory compliance. They are seeking a skilled
Regulatory Affairs Officer
to join their team and play a key role in ensuring global regulatory compliance and supporting product registrations.

The Role:

As a Regulatory Affairs Officer, you will be responsible for developing regulatory strategies, managing product license registrations worldwide, and advising on compliance requirements. This is an exciting opportunity to work in a fast-paced environment where your expertise will directly contribute to the success of the business.

Key Responsibilities:

  • Prepare and compile regulatory documentation and coordinate submissions for global markets, including US, EU, Canada, and others.
  • Advise internal teams on data requirements for successful license applications.
  • Develop and maintain product labelling requirements and liaise with stakeholders.
  • Monitor regulatory changes and maintain compliance with ISO13485, IVD Directive 98/79/EC, IVD Regulation 2017/746, FDA CFRs, and other global standards.
  • Maintain technical files and regulatory documents for multiple territories.
  • Communicate effectively with regulatory authorities and external bodies.
  • Support process improvements and provide guidance and training to team members.

What We're Looking For:

  • A relevant degree or equivalent experience in regulatory affairs.
  • Previous experience in regulatory submissions and compliance within medical devices or related industries.
  • Strong knowledge of CE and FDA regulations, including PMA, BLA, and 510(k) submissions.
  • Excellent technical writing skills and proficiency in MS Office.
  • Ability to work independently and collaboratively in a fast-paced environment.
  • Exceptional attention to detail, time management, and problem-solving skills.

Desirable:

  • Experience working within an FDA-licensed manufacturing facility.
  • Previous involvement in global regulatory submissions beyond core regions.

Why Apply?

This is a fantastic opportunity to join a forward-thinking organisation that values innovation, collaboration, and continuous improvement. Our client offers a supportive environment where your contributions will make a real impact.

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