Principal Regulatory Affairs Specialist, IVDR

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Danaher Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

🔬 Science

🤝 B2B

Biotechnology • Science • B2B

Danaher Corporation is a leading global life sciences and diagnostics innovator that develops and supplies instruments, technologies, software, and services to accelerate scientific research, biotechnology development, and clinical diagnostics. The company operates through businesses focused on biotechnology tools, diagnostics platforms, and life sciences products, leveraging the Danaher Business System and an acquisition-driven strategy to scale technologies and support customers across academia, pharmaceutical and biotech companies, and clinical laboratories.

📋 Description

• Lead the regulatory strategy, implementation and sustainment of IVDs in the UK market. • Liaise with regulatory authorities like the Medicines and Healthcare products Regulatory Agency (MHRA) and act as an administrator for related databases such UK MHRA DORS and EUDAMED. • Recommend regulatory strategy for planned product changes for UKCA and IVDR. • Prepare and maintain UKCA and IVDR Technical Documentation. • Prepare regulatory submissions and submit change notification to the notified body and MHRA. • RA lead for notified body technical reviews, surveillance reviews and certificate renewals. Including leading cross functional teams for gathering review responses. • Lead interactions with notified body / MHRA as appropriate. • Monitor the UK and EU IVD regulatory landscape and drive implementation of changes to regulations, standards and guidelines. • Serve as representative in UK and EU associations, gathering regulatory intelligence and advocating to influence regulatory policy. • Collaborate with cross functional teams. • Mentor and coach other associates and cross functional teams as needed.

🎯 Requirements

• Bachelor’s degree in Life Science or related field + 8 years’ experience in the IVD or Medical Device industry or Master’s degree in a Life Science or related field + 6 years’ experience in the IVD or Medical Device industry. • 4+ years of Regulatory Affairs experience with in vitro diagnostic and/or medical devices, including hands-on experience with EU IVDR/MDR, UKCA requirements, and technical documentation management. • Strong knowledge of global regulatory requirements and demonstrated ability to interpret regulations, assess compliance impacts, and support regulatory strategies throughout the product lifecycle. • Solid understanding of Quality Management Systems (QMS), including the application of quality principles, risk management, change control, and post-market activities within a regulated environment. • Proven ability to work effectively in cross-functional teams and communicate regulatory requirements to both technical and non-technical stakeholders. • Experience interacting with notified bodies and regulatory authorities, supporting submissions, audits, technical reviews, and compliance activities. • Hands-on experience with MHRA CTDA regulation and submissions is an advantage.

🏖️ Benefits

• Comprehensive, competitive benefit programs • Health care program • Paid time off