Description
Job DescriptionA Southern California, California based Class III medical device company is seeking a Manager of Regulatory Affairs. The Manager will have responsibilities to support the product in the EU as well as assist/prepare submissions in theU.S.and other international markets. The ideal candidate will have experience with IDE and PMA submissions.
Primary Responsibilities:
- Serving as regulatory affairs member on cross-functional teams, advising R&D, Clinical, and Marketing.
- Sit on product development core teams
- Ability to mentor and educate others daily
- Create, write, and submit regulatory filings in theUnited States,Europe, and other International markets including IDE, PMA, and Technical Files.
- Review documents of all types on a daily basis
- Ability to work on multiple projects simultaneously independently and collaboratively
- Work directly on approving labeling, including IFU's and packaging.
- Contribute to the development of the project plan for design control
- Represent the Regulatory Affairs team in Specifications and Product Plans as well as Design Reviews when applicable
Job Requirements:
- Exceptional written and analytical skills
- Thorough understanding ofU.S.and International regulatory requirements
- Thorough knowledge of FDA regulations and ability to understand their process
- Ability to mentor and educate colleagues
- Self-starter, team player, and exceptional attention to detail
- B.A./B.S. (Life science or engineering preferred)
- 5+ years of Regulatory Affairs experience desired
- 3+ years of domestic or international device experience
To find out more about Real please visit www.realstaffing.com