Description
A San Francisco Bay Area Class III medical device start-up is seeking a Manager of Regulatory Affairs. With commercial products in Europe, 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.Primary Responsibilities:
- Serving as regulatory affairs member on cross-functional teams, advising R&D, Clinical, and Marketing.
- Create, write, and submit regulatory filings in theUnited States,Europe, and other International markets.
- Work with international distribution to obtain product approvals inEastern Europe,Israel,South Africa, Latin America,Middle Eastand other International markets.
- Work closely with the Vice President with IDE study, and preparation of modular PMA as needed.
Job Requirements:
- Exceptional written and communication skills.
- Exceptional organizational skills.
- Self-starter, team player, and exceptional attention to detail.
- 4-year degree (Scientific background a plus).
- 3+ years of domestic or international device experience.
To find out more about Real please visit www.realstaffing.com