The Director of Regulatory Affairs will be responsible for the coordination, compilation and submission of biologics and medical device applications in addition to other various submissions to regulatory agencies. This person will be responsible for supporting and guiding the developing and implementing Chemical and Manufacturing Controls (CMC). This role will also provide guidance to project teams on the current regulatory framework from the Food and Drug Administration (FDA) to ensure the added value to the business from the commercialization of medical products. The Director of Regulatory Affairs will be responsible for managing supplier and distributor qualifications and the company’s auditing program as well as maintaining voluntary accreditations, state licenses and establishment registrations and listings.
Bachelor of Science or Arts in a relevant discipline is required.
Minimum of 7 years Tissue Bank, Medical Device, Biologics or Pharmaceutical experience with 4 years management experience preferred.