Senior Manager, Regulatory Affairs

Leica Biosystems

Remote
Global regulatory strategies
Ivds, companion diagnostics
Fda and eu regulatory requirements
The Senior Manager, Regulatory Affairs is responsible for developing and executing global regulatory strategies for high-complexity diagnostics including but not limited to IVDs, Companion Diagnostics and digital pathology in the clinical oncology space

Job Summary

  • The Senior Manager, Regulatory Affairs is responsible for developing and executing global regulatory strategies for high-complexity diagnostics including but not limited to IVDs, Companion Diagnostics and digital pathology in the clinical oncology space.
  • This individual will lead cross-functional regulatory initiatives, partnering with internal teams and external stakeholders to enable successful global commercialization of innovative technologies (including but not limited to IDEs; Performance Study Applications; IVDR TF in EU and 510k and PMA in USA).
  • Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.

Matching Summary

The Senior Manager, Regulatory Affairs is responsible for developing and executing global regulatory strategies for high-complexity diagnostics including but not limited to IVDs, Companion Diagnostics and digital pathology in the clinical oncology space.

Skills & Requirements

Must-have

  • global regulatory strategies
  • IVDs, Companion Diagnostics
  • FDA and EU regulatory requirements
  • new product development
  • global regulatory submissions
  • engage and negotiate with agencies

Nice-to-have

  • continuous improvement culture
  • diverse and collaborative community
  • accelerate your potential
  • innovating at the speed of life
  • driving continuous improvement

Key Requirements

  • Bachelor’s, Master’s, or PhD in scientific or engineering
  • Extensive progressive experience
  • Proven track record in developing strategies
  • Experience supporting clinical trials is a plus
  • Ability to travel 15% travel

Work Rights

Not specified

Tailored Resume

Cover Letter