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 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
- Support 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 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
Requirements:
- 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
- Ability to manage multiple priorities in a fast-paced environment
- Fluent 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@mackinnon-bruce.com.