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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
- Create and implement product approval and maintenance strategy for Class III devices in China and APAC region
- Ensure compliance with post-market requirements in China and APAC region
- 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
- Provide input to labeling and marketing programs in reference to regulatory requirements
- 10 or more years in the area of worldwide regulatory affairs (both submission and compliance) at medical device companies.
- Experience with Class III medical device submissions in Asia-Pacific region, China preferred
- Proficient in Mandarin (speaking, writing)
- Keep abreast of new or developments in various regulations and advise Regulatory Affairs management as necessary
Minimum B.S. degree in a technical discipline or equivalent experience
M.S. degree in technical discipline preferred or equivalent experience