Senior Manager, Regulatory Affairs
About The Position
The Senior Manager, Regulatory Affairs develops and executes global regulatory strategies for high-complexity hardware and software products, including in vitro diagnostics (IVDs) and digital pathology products in clinical oncology. The role leads cross-functional regulatory initiatives and partners with internal teams and external stakeholders to support global commercialization, including IDEs, Performance Study Applications, EU IVDR Technical Files, and U.S. 510(k) submissions. The role leads Regulatory Affairs professionals responsible for developing, authoring, and maintaining global submissions. It collaborates with global and cross-functional teams to define regulatory strategies, provides regulatory input into program plans, and works with external partners on study designs and submissions. The Senior Manager engages with regulatory agencies to support product clearance or approval, monitors changing regulations and competitive landscapes, shares expertise across Leica and Danaher sites, and uses Danaher Business System tools to drive continuous improvement. This position reports to the Senior Director, Regulatory Affairs and is part of the Regulatory Affairs Team. It requires 15% travel, including overnight travel within the territory or to other locations.
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.
- Five or more years of progressive experience supporting new product development and sustaining high-complexity diagnostic products.
- Proven track record developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including 510(k) submissions.
Nice To Haves
- Experience supporting clinical trials and a strong understanding of regulatory requirements across international markets.
- Deep regulatory expertise in developing and globally commercializing complex, high-risk products, balancing immediate problem-solving with long-term strategic outcomes and risk-benefit analysis.
- Ability to lead effectively in matrixed and cross-cultural environments, drive timely decisions and issue resolution, enable resource agility, and model accountability and integrity.
- Ability to communicate complex and sensitive information clearly to diverse audiences, build consensus, write and document effectively, and use sound judgment to influence and lead through change.
Responsibilities
- Lead a team of Regulatory Affairs professionals responsible for developing, authoring, and maintaining global regulatory submissions, including 510(k) submissions, EU IVDR Technical Files, and STED.
- Define submission requirements, standardize processes, optimize timelines, and adapt plans as needed.
- Collaborate globally and cross-functionally with Clinical Affairs, Business Development, Quality Assurance, Research and Development, and Program Management to define and execute regulatory strategies.
- Provide regulatory input for program planning, including resource needs, budgets, and timelines.
- Align with external partners on study designs and submission strategies.
- Engage and negotiate with global regulatory agencies to achieve product clearance or approval.
- Monitor evolving regulations, guidance, and competitive landscapes.
- Share regulatory expertise across Leica and Danaher sites and contribute to cross-functional initiatives.
- Apply Danaher Business System tools to drive continuous improvement and measurable results.
Benefits
- Paid time off
- Medical, dental, and vision insurance
- 401(k)
- Bonus or incentive pay eligibility
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What This Job Offers
Job Type
Full-time
Career Level
Senior
