Head Of Regulatory Affairs North America

Fresenius Medical Care

Waltham, MA, United States
12+ years in medical device
Strong knowledge of fda regulations
Experience in senior managerial role
The Head of Regulatory Affairs will lead a team of regulatory professionals and ensure compliance with FDA and other regulatory bodies

Job Summary

  • The Head of Regulatory Affairs will lead a team of regulatory professionals and ensure compliance with FDA and other regulatory bodies.
  • This role involves managing complex regulatory projects and fostering effective relationships with health authority reviewers.
  • The position offers a comprehensive benefits package including medical, dental, and vision insurance, along with a 401(k) with company match.

Matching Summary

The Head of Regulatory Affairs will lead a team of regulatory professionals and ensure compliance with FDA and other regulatory bodies.

Skills & Requirements

Must-have

  • 12+ years in Medical Device
  • Strong knowledge of FDA regulations
  • Experience in senior managerial role

Nice-to-have

  • Leadership and coaching skills
  • Ability to work cross functionally
  • Strong interpersonal skills

Key Requirements

  • Bachelor’s Degree in Engineering or Life Science
  • 5+ years in a director level role
  • Knowledge of Canadian Device approval process

Work Rights

Not specified

Tailored Resume

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