Sr. Regulatory Affairs Specialist

Envista

Brea, CA, USA
Base: $94,500 - $141,800; bonus/equity: annual per...
On-site
Us 510(k) submissions
Eu mdr
Health canada medical device regulations
Envista is seeking a Sr. Regulatory Affairs Specialist for their Brea, CA location, responsible for developing regulatory strategies and preparing submissions for medical devices. The ideal candidate should have extensive experience in regulatory affairs within the medical device sector, particularly with 510(k) submissions and EU MDR compliance

Job Summary

  • The Sr. Regulatory Affairs Specialist will be primarily responsible for supporting the development of RA strategies for new product development for a range of dental restorative, endodontic, and rotary products.
  • Responsibilities include preparing/submitting regulatory filings for US 510(k)s, Canada, and EU MDR.
  • The role requires expertise in domestic and/or international medical device regulations, including but not limited to 510ks, European Union (EU) Medical Devices Regulation (MDR), and/or global registration requirements.

Matching Summary

Match Score: 85

Envista is seeking a Sr. Regulatory Affairs Specialist for their Brea, CA location, responsible for developing regulatory strategies and preparing submissions for medical devices. The ideal candidate should have extensive experience in regulatory affairs within the medical device sector, particularly with 510(k) submissions and EU MDR compliance.

Salary

Base: $94,500 - $141,800; Bonus/Equity: annual performance bonus; Benefits: medical/dental/vision benefits, 401K match

Skills & Requirements

Must-have

  • US 510(k) submissions
  • EU MDR
  • Health Canada Medical Device Regulations
  • UDI strategy implementation
  • GUDID submissions

Nice-to-have

  • continuous improvement activities
  • mentors and guides junior personnel
  • Quality System Regulations expertise

Key Requirements

  • 7+ years of relevant work experience in medical, pharmaceutical, healthcare or a regulated industry
  • 5+ years of Regulatory Affairs work experience
  • Bachelor’s degree in a related field

Work Rights

Not specified

Tailored Resume

Cover Letter