Regulatory Affairs Manager

Boston  ‐ Onsite
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Description

Job Description

A 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)

- 8+ years of Regulatory Affairs experience desired

- 5+ years of domestic or international device experience

To find out more about Real please visit www.realstaffing.com
Start date
06/2013
From
Real Staffing US
Published at
06.06.2013
Project ID:
546710
Contract type
Permanent
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