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Regulatory Affairs Officer
Location: Edinburgh- On site
Employment Type: Permanent
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.
Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy.
