Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Leica Biosystems, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Leica Biosystems, we're not just shaping the future of cancer diagnostics - we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most.
When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact.
Learn about the Danaher Business System which makes everything possible.
Job Description
The Senior Manager, Regulatory Affairs is responsible for developing and executing global regulatory strategies for high-complexity diagnostics including but not limited to IVDs, Companion Diagnostics and digital pathology in the clinical oncology space. This individual will lead cross-functional regulatory initiatives, partnering with internal teams and external stakeholders to enable successful global commercialization of innovative technologies (including but not limited to IDEs; Performance Study Applications; IVDR TF in EU and 510k and PMA in USA).
This position reports to the Senior Director, Regulatory Affairs and is part of the Global Regulatory Affairs Team located in Newcastle, UK and will be an on-site role.
Responsibilities
* Lead a team of Regulatory Affairs Professionals responsible for the development, authorship, and maintenance of global regulatory submissions (e.g., 510(k), PMA, EU IVDR Technical Files, STED) by defining requirements, standardizing processes, optimizing timelines, and adapting plans as needed.
* Collaborate globally and cross-functionally (e.g., Clinical Affairs, Business Development, QA, R&D, Program Management) to define and execute regulatory strategies for Leica Biosystems technologies in cancer diagnostics, IVD, and Companion Diagnostics markets.
* Provide regulatory input for program planning, including resource needs, budgets, and timelines, while aligning with external partners on study designs and submission strategies.
* Engage and negotiate with global regulatory agencies to achieve product clearance/approval, while staying current on evolving regulations, guidance, and competitive landscapes.
Requirements
* Bachelor's, Master's, or PhD in a scientific or engineering discipline.
* In-depth working knowledge of FDA and EU regulatory requirements for IVD devices.
* Extensive progressive experience supporting new product development and sustaining high-complexity diagnostic products.
* Proven track record in developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including 510k and PMA submissions.
* Experience supporting clinical trials is a plus, along with strong understanding of regulatory requirements across international markets.
Travel and Other Requirements
* Ability to travel - 15% travel, overnight, within territory or locations
Nice to Have
* Applies deep regulatory expertise to the development and global commercialization of complex, high-risk products, balancing short-term problem-solving with long-term strategic outcomes and risk-benefit analysis.
* Leads effectively in matrixed and cross-cultural environments, driving timely decisions, issue resolution, and resource agility while setting high expectations and modeling accountability and integrity.
* Communicates complex and sensitive information clearly across diverse audiences; builds consensus, demonstrates strong writing and documentation skills, and uses sound judgment to influence and lead through change.
Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
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