Senior Manager, Regulatory Affairs

Danaher•Vista, CA

15h•$155,000 - $165,000

About The Position

The Senior Manager, Regulatory Affairs develops and executes global regulatory strategies for complex hardware and software products, including in vitro diagnostic (IVD) devices and digital pathology products used in clinical oncology. The role leads cross-functional regulatory initiatives and works 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 position leads Regulatory Affairs Professionals responsible for developing, authoring, and maintaining global regulatory submissions. It defines requirements, standardizes processes, optimizes timelines, and adapts plans as needed. The role also provides regulatory input to program planning, including resource requirements, budgets, and timelines; collaborates on study designs and submission strategies; and engages with global regulatory agencies to obtain product clearance or approval. The Senior Manager shares regulatory expertise across Leica Biosystems and Danaher sites and uses Danaher Business System tools to support continuous improvement and measurable results. 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 assigned territory or to other locations. The annual salary range is $155,000–$165,000, with eligibility for bonus or incentive pay. The company offers paid time off, medical, dental, and vision insurance, and a 401(k) to eligible employees.

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.
At least 5 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.
Ability to travel 15%, including overnight travel within the territory or to other locations.

Nice To Haves

Experience supporting clinical trials.
Strong understanding of regulatory requirements across international markets.
Deep regulatory expertise applied to development and global commercialization of complex, high-risk products, including short-term problem-solving, long-term strategic outcomes, and risk-benefit analysis.
Effectiveness in matrixed and cross-cultural environments, driving timely decisions, issue resolution, and resource agility while modeling accountability and integrity.
Ability to communicate complex and sensitive information clearly to diverse audiences, build consensus, demonstrate strong writing and documentation skills, and influence and lead through change.

Responsibilities

Lead a team of Regulatory Affairs Professionals in 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 regulatory plans as needed.
Collaborate globally and cross-functionally with teams such as 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.
Stay current on evolving regulations, guidance, and competitive landscapes.
Share regulatory expertise across Leica Biosystems and Danaher sites and contribute to cross-functional initiatives.
Apply Danaher Business System tools to drive continuous improvement and measurable results.