Principal, Regulatory Affairs

The Principal, Regulatory Affairs is responsible for developing and executing global regulatory strategies for high-complexity diagnostics including IVDs, Companion Diagnostics, and digital pathology in the clinical oncology space. The role partners with internal teams and external stakeholders to support successful global commercialization of innovative technologies, including IDEs, Performance Study Applications, and regulatory submissions (EU IVDR, FDA 510(k), PMA, 510(k) Pre-Submissions, Health Canada filings).

This position reports to the Senior Manager, Regulatory Affairs and is part of the Global Regulatory Affairs Team located in Newcastle, UK. This is a full‑time on‑site role.

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• Lead Regulatory Affairs representation on new product development teams for IVD medical device and RUO products.
  
• Develop and execute global regulatory strategies, including FDA 510(k), Pre‑Submissions, Health Canada filings, and IVDR Technical File authoring.
  
• Provide regulatory guidance on product labelling, marketing materials, and product changes to ensure compliance.
  
• Collaborate cross‑functionally with global teams and contribute Regulatory Affairs input on project teams.
  
• Engage and negotiate with global regulatory agencies to achieve product clearance/approval while staying current on evolving regulations and competitive landscapes.
  
• Share regulatory expertise across Leica and Danaher sites, contribute to cross‑functional initiatives, and apply Danaher Business System tools to drive continuous improvement and measurable results.
  

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• Bachelor’s degree in science or engineering or equivalent experience.
  
• Extensive experience with regulatory strategy and submissions for high‑complexity diagnostic products in a global market; experience supporting clinical trials is a plus.
  
• In‑depth working knowledge of FDA, Health Canada, and EU regulatory requirements for IVD devices.
  
• Proven track record in developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including IVDR, 510(k), PMA, and Health Canada submissions.
  
• Strong analytical mindset with a continuous drive for regulatory intelligence and minimal supervision needed.
  

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• Ability to travel up to 15% of the time, including overnight trips and travel within designated territories or locations.
  

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• Deep regulatory expertise applied to the development and global commercialization of complex, high‑risk products, balancing short‑term problem‑solving with long‑term strategic outcomes.
  
• Effectiveness in matrixed and cross‑cultural environments, driving timely decisions, issue resolution, and resource agility while setting high expectations and modeling accountability and integrity.
  
• Excellent communication of complex and sensitive information across diverse audiences; strong writing and documentation skills; sound judgment to influence and lead through change.
  

Leica Biosystems is a Danaher operating company focused on advancing cancer diagnostics. Our mission is “Advancing Cancer Diagnostics, Improving Lives.” Join our team to help develop diagnostic solutions that impact patient care worldwide.