Program Manager, Regulatory Affairs

BS degree is required with a degree in science, technology, engineering, or mathematics preferred. A minimum of 5 years of relevant experience in the biotech industry required; a minimum of 3 years of experience in developing regulatory strategies, planning and preparing regulatory submissions required. Experience with regulatory product lifecycle management preferred. Regulatory experience with development of Medical Device and Biologic products required, including PMA, BLA and/or 510(k). Must have a good working knowledge of relevant regulations and industry standards. Strong organizational, interpersonal and written/verbal communication skills required. Experience with technical aspects of product development and manufacturing. Other skills include working knowledge of FDA and International Biologics/Drug/Device regulations, ability to prioritize and multi-task projects independently, and strong organizational skills.