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 improvemen...