Compliance / Business Risk Officer in Scotland

Mackinnon Bruce are partnered with a well-established and growing international in-vitro diagnostics (IVD) organisation to appoint a Regulatory Affairs Officer within its Regulatory Affairs function. This is a hands-on regulatory role with international exposure, offering the opportunity to contribute to regulatory strategy and execution across multiple global markets. The position plays a key role in supporting product registrations, ensuring ongoing regulatory compliance, and maintaining technical documentation throughout the product lifecycle.

Working closely with cross-functional teams including R&D, Quality, Manufacturing, and Commercial, the Regulatory Affairs Officer will support regulatory submissions, liaise with regulatory authorities, and contribute to the continuous improvement of regulatory processes and systems within a fast-paced IVD environment.

• Support the development and execution of regulatory strategies for IVD products across global markets
• Prepare, compile, submit, and maintain regulatory documentation for regions including EU, US, Canada, and other international territories
• Ensure compliance with ISO 13485, IVD Directive 98/79/EC, IVDR (EU) 2017/746, FDA 21 CFR, and CMDR Part 1
• Coordinate regulatory submissions and advise internal teams on data and documentation requirements
• Contribute to the development and review of product labelling, IFUs, and packaging to ensure regulatory compliance
• Liaise with regulatory authorities, notified bodies, customers, and external partners as required
• Maintain regulatory documentation in line with quality system and change control requirements
• Contribute to regulatory intelligence activities, monitoring regulatory updates and guidance
• Support audits, inspections, and general regulatory compliance activities
• Provide guidance and support to other Regulatory Affairs team members as needed

Relevant degree and/or practical experience in a Regulatory Affairs environment. Previous experience within medical devices and/or IVD. Working knowledge of CE marking and FDA regulatory requirements. Understanding of regulatory submissions such as 510(k), PMA, BLA, or CE technical documentation. Strong technical writing and documentation skills. Experience working to ISO 13485 and within a regulated quality system. Fluent English (written and spoken). Experience within an FDA-licensed manufacturing environment and exposure to global regulatory submissions is advantageous.