Job Title

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.About the Role: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.Key Responsibilities:Support the development and execution of regulatory strategies for IVD products across global marketsPrepare, compile, submit, and maintain regulatory documentation for regions including EU, US, Canada, and other international territoriesEnsure compliance with ISO 13485, IVD Directive 98/79/EC, IVDR (EU) 2017/746, FDA 21 CFR, and CMDR Part 1Coordinate regulatory submissions and advise internal teams on data and documentation requirementsSupport the preparation and maintenance of technical files and product registrations (EU, US, Canada, Japan, Brazil, etc.)Contribute to the development and review of product labelling, IFUs, and packaging to ensure regulatory complianceLiaise with regulatory authorities, notified bodies, customers, and external partners as requiredMaintain regulatory documentation in line with quality system and change control requirementsContribute to regulatory intelligence activities, monitoring regulatory updates and guidanceSupport audits, inspections, and general regulatory compliance activitiesProvide guidance and support to other Regulatory Affairs team members as neededRequirements:Relevant degree and/or practical experience in a Regulatory Affairs environmentPrevious experience within medical devices and/or IVDWorking knowledge of CE marking and FDA regulatory requirementsUnderstanding of regulatory submissions such as 510(k), PMA, BLA, or CE technical documentationStrong technical writing and documentation skillsExperience working to ISO 13485 and within a regulated quality systemAbility to manage multiple priorities in a fast-paced environmentFluent English (written and spoken)Experience within an FDA-licensed manufacturing environment and exposure to global regulatory submissions is advantageous.If you are interested in discussing the position further, please apply or reach out to me directly at Ben.birkhead@.