Manager, Regulatory Affairs

Nuvasive Inc

510(k) submission experience
Ide and pma approval experience
Knowledge of fda regulations
The Manager, Regulatory Affairs is responsible for preparing and filing submissions to the FDA

Job Summary

  • The Manager, Regulatory Affairs is responsible for preparing and filing submissions to the FDA.
  • This role requires effective relationship building with various stakeholders including the FDA and healthcare providers.
  • The company values innovation and teamwork to improve patient outcomes.

Matching Summary

The Manager, Regulatory Affairs is responsible for preparing and filing submissions to the FDA.

Skills & Requirements

Must-have

  • 510(k) submission experience
  • IDE and PMA approval experience
  • Knowledge of FDA regulations

Nice-to-have

  • Strong interpersonal skills
  • Detail-oriented mindset
  • Ability to work in a team

Key Requirements

  • BS degree in engineering or science-related field
  • Minimum of 8 years’ experience in medical device industry
  • Minimum of 3 years’ experience in regulatory capacity

Work Rights

Not specified

Tailored Resume

Cover Letter