Description
Job DescriptionASan Diego,Californiabased Class III medical device company is seeking a Principal Regulatory Affairs Specialist. The Principal Regulatory Affairs Specialist will interact with the Regulatory Affairs Management team in prioritizing regulatory activities and projects to meet department and corporate goals. The ideal candidate will have experience with IDE and PMA submissions.
Primary Responsibilities:
- Serving as regulatory affairs liaison on cross-functional teams
- 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.
- Work closely with the Management with preparation of IDE and PMA supplements.
- 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)
- 3+ years of Regulatory Affairs with a medical device company
To find out more about Real please visit www.realstaffing.com