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