Job Summary
A healthcare research company is searching for a person to fill their position for a Remote Regulatory Affairs Senior Director.
Core Responsibilities of this position include:
- Leading regulatory contact for FDA, Health Authority negotiations on GRAIL MCED products
- Providing regulatory support towards new and currently marketed products
- Assessing impact of new regulations and work with cross-functional partner
Skills and Requirements Include:
- B.S./B.A. in a science or related life science field
- Minimum of 12 years’ experience in regulatory, R&D, clinical affairs, and quality in IVD
- Experience with regulatory submissions for PMA, IDE and CE Mark
- Track record of leadership, providing sound regulatory judgment/ideas
- Experience with Microsoft based applications and general knowledge of PC functions necessary
- Ability to interpret and respond to requests from regulatory agencies
