In-depth fda and eu regulatory requirements knowledge
Experience with 510k and pma submissions
Expertise in eu ivdr technical files preparation
Leica Biosystems, part of Danaher, seeks a Senior Manager of Regulatory Affairs to drive global regulatory strategies in high-complexity diagnostics related to cancer. The ideal candidate will have extensive experience in regulatory submissions and collaboration across cross-functional teams
Job Summary
The Senior Manager will lead a team responsible for developing and executing global regulatory strategies for high-complexity cancer diagnostics.
This role involves collaborating with cross-functional teams to define and execute regulatory strategies for innovative technologies in the IVD and Companion Diagnostics markets.
Leica Biosystems offers comprehensive benefit programs that add value to employees' lives beyond the job while fostering a culture of belonging and continuous improvement.
Matching Summary
Match Score: 85
Leica Biosystems, part of Danaher, seeks a Senior Manager of Regulatory Affairs to drive global regulatory strategies in high-complexity diagnostics related to cancer. The ideal candidate will have extensive experience in regulatory submissions and collaboration across cross-functional teams.
Skills & Requirements
Must-have
In-depth FDA and EU regulatory requirements knowledge
Experience with 510k and PMA submissions
Expertise in EU IVDR Technical Files preparation
Leadership of Regulatory Affairs Professionals team
Strategic planning for global commercialization
Nice-to-have
Experience supporting clinical trials
Understanding of international market regulations
Ability to apply Danaher Business System tools
Strong cross-cultural communication skills
Proven track record in risk-benefit analysis
Key Requirements
Bachelor's, Master's, or PhD in scientific or engineering discipline
Extensive progressive experience in new product development
Proven track record in preparing global submissions
Experience leading cross-functional regulatory initiatives