Global Regulatory Lead for IVD & Diagnostics

Regulatory Jobs; Vista (CA); On-site; USD 155,000 - 165,000; Full time

Benefits offered by this job

Bonus eligible

Medical/dental/vision insurance

401(k)

Job summary

Leica Biosystems, part of Danaher, seeks a Senior Manager, Regulatory Affairs to lead regulatory strategies for high-complexity hardware and software products including IVDs and digital pathology in clinical oncology.

You will collaborate with Clinical Affairs, QA, R&D and program management to enable global commercialization, manage submissions, and drive DBS-based improvements across sites.

Qualifications

• Extensive regulatory experience with high-complexity diagnostic products.
• Proven track record developing and executing regulatory strategies and submissions.
• Experience supporting clinical trials and knowledge of international regulations.

Responsibilities

• Lead global regulatory submissions (510(k), EU IVDR Tech Files, STED).
• Define requirements, standardize processes, and manage timelines.
• Collaborate with Clinical Affairs, QA, R&D and program management.
• Engage with global regulatory agencies to achieve clearance/approval.
• Share regulatory expertise and drive continuous improvement using DBS.

Skills

Regulatory leadership

Global regulatory strategy

Cross-functional collaboration

FDA & EU regulatory

Regulatory submissions

Education

Bachelor’s, Master’s or PhD in a scientific or engineering discipline

Job description

Leica Biosystems, part of Danaher, seeks a Senior Manager, Regulatory Affairs to lead regulatory strategies for high-complexity hardware and software products including IVDs and digital pathology in clinical oncology.

You will collaborate with Clinical Affairs, QA, R&D and program management to enable global commercialization, manage submissions, and drive DBS-based improvements across sites.