Senior Regulatory Affairs Manager — Global Diagnostics

Danaher Corporation; Vista (CA); In loco; USD 155.000 - 165.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus eligible

Healthcare benefits

401(k) plan

Descrizione del lavoro

Leica Biosystems, part of Danaher, seeks a Senior Manager of Regulatory Affairs to lead global regulatory submissions for high-complexity diagnostic products, including IVDs and digital pathology. The role partners with Clinical Affairs, QA, R&D, and more to align strategies and resources.

You will drive regulatory planning, negotiate with agencies, and guide teams across regions to enable timely global commercialization.

Competenze

• 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 (5+ years).
• Proven track record in developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including 510k submissions.
• Experience supporting clinical trials is a plus, along with strong understanding of regulatory requirements across international markets.

Mansioni

• Lead a team of Regulatory Affairs Professionals responsible for the development, authorship, and maintenance of global regulatory submissions (e.g., 510(k), EU IVDR Technical Files, STED).
• Collaborate globally and cross-functionally to define and execute regulatory strategies for Leica Biosystems technologies.
• 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 and competitive landscapes.
• Share regulatory expertise across Leica and Danaher sites, contribute to cross-functional initiatives, and apply DBS tools to drive continuous improvement.

Descrizione del lavoro

Leica Biosystems, part of Danaher, seeks a Senior Manager of Regulatory Affairs to lead global regulatory submissions for high-complexity diagnostic products, including IVDs and digital pathology. The role partners with Clinical Affairs, QA, R&D, and more to align strategies and resources.

You will drive regulatory planning, negotiate with agencies, and guide teams across regions to enable timely global commercialization.