My client, a Class-III implantable medical device company based in the Bay Area, has an immediate need for a Senior Manager of Regulatory Affairs to join their exciting, growing team working on next generation products.
- Development and implementation of domestic/international regulatory strategies and solutions
- Develop plans to achieve cross-functional business goals that support overall company objectives by analyzing market changes, internal customer and staffing need
- Prepare of regulatory submissions; such as CE Mark for Class II-III products, IDE's, IND's, 510(k)'s, NDA's, ANDA's, PMA's
- Interact with regulatory bodies on issues
- Works with industry groups, elected officials, and governmental personnel to advance company interests
- 8+ years work experience in Regulatory Affairs; 3+ years Regulatory Management
- Ability to drive talent; Aid in hiring, training, and continual management of regulatory department/team
- Bachelor's Degree in relevant field; advanced degree preferred
- FDA successful submissions of IDE and PMA and global submission preparation
Sthree US is acting as an Employment Agency in relation to this vacancy.