We have a current opportunity for a Senior Director Regulatory Affairs Medical Device on a permanent basis. The position has three potential locations, two on the West Coast and one on the East Coast. There is also the opportunity for this role to be remote with occasional monthly travel to one of these locations.
The Sr. Director Regulatory Affairs (Devices) is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs to cross-functional teams.
- Communicates regulatory strategy to project teams developing pharmaceutical or medical device
- Leads team of regulatory professionals to ensure successful planning and completion of regulatory activities on a worldwide basis
- Responsible for knowledge of regulatory requirements of major regions (US, EU, Japan and China) with responsibility for working with colleagues on a worldwide basis to form a global strategy
- Responsible for content of global regulatory submissions
- Directs communications and interactions with US FDA and other regulatory agencies worldwide
- Responsible for covering multiple development projects within the portfolio
- Excellence in developing global regulatory affairs strategy.
- Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance as regulatory lead on global project teams
- Able to analyze worldwide regulatory requirements to synthesize a global regulatory development strategy as evidenced by past regulatory experience
- Excellent interpersonal skills
- Exceptional communication skills (verbal and written) as evidenced by a demonstrated ability to prepare complex documents / submissions and to give presentations
- Experience working in a matrixed environment
- Ability to work independently
For further information about this position please apply.