Regulatory Affairs Officer
1 day ago
Edinburgh
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.