Regulatory Affairs Officer

General Description

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.

The following information provides an overview of the skills, qualities, and qualifications needed for this role.

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. xwzovoh

If you are interested in discussing the position further, please apply or reach out to me directly at .