Description
Mackinnon Bruce are partnered with a well-established and growing international in-vitro diagnostics (IVD) organisation to appoint a Senior Regulatory Affairs Officer within its Regulatory Affairs & Quality function.
About the Role:
This is a senior, high-impact regulatory role with a broad international scope, offering the opportunity to take ownership of regulatory strategy and execution across multiple geographies. The position plays a critical role in ensuring ongoing compliance, successful product registrations, and effective lifecycle management for a diverse IVD portfolio.
Working closely with cross-functional teams including R&D, Quality, Manufacturing, and Commercial, the Senior Regulatory Affairs Officer will act as a subject-matter expert and key regulatory contact, both internally and externally. The role also carries responsibility for mentoring junior team members and contributing to the continuous improvement of regulatory systems and processes.
Key Responsibilities:
- Lead and execute global regulatory strategies for IVD products across multiple regions
- Prepare, submit, and maintain complex regulatory submissions (including IVDR, FDA, and other international markets)
- Interpret and apply global regulatory requirements, proposing compliant and pragmatic solutions
- Act as a primary point of contact with regulatory authorities, notified bodies, and external partners
- Provide expert regulatory guidance to cross-functional project teams throughout the product lifecycle
- Manage change control activities, non-conformances, and post-market regulatory events
- Support regulatory audits and inspections, ensuring readiness and compliance
- Contribute to the development and continuous improvement of regulatory and quality systems
- Mentor and support junior Regulatory Affairs colleagues, building internal capability
Requirements:
- Significant experience in Regulatory Affairs within medical devices and/or IVDs
- Proven track record of preparing and managing complex regulatory submissions (e.g. IVDR, 510(k), PMA, BLA)
- Strong working knowledge of global regulatory frameworks (EU, US, Canada and beyond)
- Experience supporting regulatory audits and inspections
- Excellent technical writing and document review skills
- A relevant scientific degree and/or substantial regulatory affairs experience
- Professional regulatory certification (e.g. RAPS) 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
