Principal Regulatory Affairs Specialist, IVDR

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Danaher

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

🏥 Healthcare

🔬 Science

Biotechnology • Healthcare • Science

Danaher is a leading global life sciences and diagnostics innovator that applies science and technology to improve human health. Its portfolio includes businesses in biotechnology, diagnostics, and life sciences that provide instruments, tools, software and services to accelerate research, develop and deliver therapies, and enable precise and rapid diagnostics. Danaher emphasizes continuous improvement through its Danaher Business System, pursues acquisitions and partnerships to expand capabilities, and focuses on scaling scientific innovation and delivering impact at global scale.

📋 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

• Health care program • Paid time off • Professional development opportunities