Sr. Regulatory Affairs Specialist

Envista

Brea, California, United States
Base: $94,500 - $141,800; bonus/equity: annual per...
Hybrid
Us 510(k) submissions
Eu mdr
Health canada medical device regulations
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

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 total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

Matching 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.

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
  • Quality System Regulations
  • Design Controls

Nice-to-have

  • Continuous improvement activities
  • Envista Business System (EBS) implementation
  • Mentoring junior personnel
  • Cross-functional team representation

Key Requirements

  • 7+ years relevant work experience or Bachelor's degree
  • 5+ years Regulatory Affairs experience
  • Expertise in medical device regulations
  • Must reside within commutable distance to Brea, CA

Work Rights

Not specified

Tailored Resume

Cover Letter