Sr Specialist Regulatory Affairs

KNOWLEDGE, SKILLS AND ABILITIES    

Education  BA/BS, MS/MA

Experience 5 years of Regulatory experience, including 3 years international and industrial experience or equivalent.  Knowledge of devices a plus.

1. Must exhibit an exceptional degree of ingenuity, creativity, and resourcefulness to apply and/or develop highly advanced technologies, scientific principles, theories, and concepts.

2. Must be able to provide solutions to a wide range of difficult and complex problems that require the regular use of ingenuity and creativity.

3. Excellent oral and written communication skills are required in order to interact with various levels of personnel within and outside the Company.

4. Ability to perform duties under very general direction and independently perform assignments with only general criteria for expected results. 

5. Erroneous decisions or recommendations or failure to get results would normally result in serious program delays, considerable expenditure of dollars, and resources and regulatory risk to the company.

6. Some travel is required.

7. High degree of confidentiality and ethics

8. Foreign language skills a plus