This position entails management of submissions to regulatory bodies, requiring working knowledge of products under review and of relevant regulations. This individual must be enthusiastic, positive, even-tempered and effective in building working relationships with the international sales organizations, international regulatory bodies, and in-house personnel.. Experience should demonstrate dependability, flexibility and maturity.
Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 5-7 years experience in a regulated industry (e.g., medical products, nutritionals). 5-7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
APOC Point of Care
Princeton, New Jersey, United States of America
Yes, 20 % of the Time
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)