Connecting...

Regulatory Affairs- Sr. Specialist/Manager

A diagnostics company in Northern Orange County is seeking a Regulatory Affairs professional to join their team at the Sr. Specialist/Manager level. This company is growing and offers opportunity for career advancement, competitive compensation packages, and a fast-paced environment.

Responsibilities

  • Regulatory Submissions: 510(k)
  • International registration
  • Overseeing 1-2 direct reports
  • Interact with FDA and regulatory bodies
  • Support in Design Control Process
  • Drive Process Improvement
  • Work Cross-Functionally with other departments

Sthree US is acting as an Employment Agency in relation to this vacancy.