Regulatory Affairs

Los Angeles, California, United States

Posted on 07/23/2019

Position Details




Healthcare / Medical Devices


Medical / Health

Job Level:

Experienced Professional (Non-Manager)


Bachelor's Degree

Reference ID:


Don't miss this opportunity!

Project Manager- Regulatory Affairs - Medical Device

Siter-Neubauer & Associates, an MRI Network affiliate is currently conducting a search for a Project Manager of Regulatory Affairs – Medical Device


Our Client is a leader in Medical Device technology and manufacturing with a worldwide customer base. Located in California, there is plenty of opportunity for advancement in this growing company. The compensation, benefits and opportunity for advancement are all very attractive.

Project Manager- Regulatory Affairs – California

Department: RA / RCA


Purpose of the Job

Responsible for the coordination and administration of regulatory submission and compliance activities for China.


Tasks & Responsibilities

  1. Create and implement product approval and maintenance strategy for Class III devices in China and APAC region
  2. Ensure compliance with post-market requirements in China and APAC region
  3. Provide input to engineering teams to assure that worldwide regulatory requirements and standards are incorporated in the product development process and design/manufacture of the product
  4. Provide input to labeling and marketing programs in reference to regulatory requirements
  5. 10 or more years in the area of worldwide regulatory affairs (both submission and compliance) at medical device companies.
  6. Experience with Class III medical device submissions in Asia-Pacific region, China preferred
  7. Proficient in Mandarin (speaking, writing)
  8. Keep abreast of new or developments in various regulations and advise Regulatory Affairs management as necessary


Basic Education

Minimum B.S. degree in a technical discipline or equivalent experience

M.S. degree in technical discipline preferred or equivalent experience