Senior Director, Regulatory Affairs

Danaher UK

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Senior leadership managing cross-functional teams
Global regulatory strategy for medical devices
Fda and eu notified bodies interactions
** Danaher UK is seeking a Senior Director of Regulatory Affairs to lead and execute global regulatory strategies, enhancing market access and compliance for their diagnostics and biotechnology solutions. The role requires significant leadership experience and collaboration with cross-functional teams to drive innovation and improve patient care. **

Job Summary

  • You will develop and execute global regulatory strategies that align with business objectives to accelerate approvals across international markets.
  • The role involves serving as the strategic interface with global health authorities including the FDA and EU Notified Bodies to ensure compliance.
  • Radiometer is united by a shared commitment to innovate for tangible impact in improving global healthcare with reliable patient diagnoses.

Matching Summary

Match Score: 75

** Danaher UK is seeking a Senior Director of Regulatory Affairs to lead and execute global regulatory strategies, enhancing market access and compliance for their diagnostics and biotechnology solutions. The role requires significant leadership experience and collaboration with cross-functional teams to drive innovation and improve patient care. **

Skills & Requirements

Must-have

  • Senior leadership managing cross-functional teams
  • Global regulatory strategy for medical devices
  • FDA and EU Notified Bodies interactions
  • Quality Management System (QMS) oversight
  • Process optimization using Danaher Business System

Nice-to-have

  • Experience leading Quality function
  • Clinical Affairs partnership experience
  • Regulatory policy advocacy involvement
  • Continuous improvement culture mindset

Key Requirements

  • Advanced degree in scientific or engineering discipline
  • Proven senior leadership experience with direct reports
  • Track record of leading global regulatory submissions
  • Demonstrated ability to lead organizational transformation

Work Rights

Not specified

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