Description
The Senior Manager/Associate Director of Regulatory Affairs is responsible for domestic and international submissions for class III devices. The candidate will be responsible for creating and implementing regulatory strategy and preparing submissions for the FDA and International Health Agencies.Responsibilities include:
- Develop and implement regulatory strategies in collaboration with senior team.
- Ensure deadlines are met, including filings for new and existing products
- Hands-on writing of U.S. FDA submissions, in particular, PMA submissinos
- Supervise more junior level staff
- Interact with domestic and international health agencies
Sills and experience:
- Experience with PMA submissions
- Experience with combination products a plus
- Strong communication and project management skills
- Ability to meet strict deadlines
To find out more about Real please visit www.realstaffing.com