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Regulatory Affairs Program Manager

3 months ago

Canton, United States firstPRO, Inc Full time

firstPRO is now accepting resumes for a Program Manager of Regulatory Affairs in Canton, MA. This is a direct hire role and onsite 2-3 days per week.

What you need to achieve:

  • 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/Abilities:

  • Working knowledge of FDA and International Biologics/Drug/Device regulations is preferred.
  • In addition, prior experience with medical devices development and registrations is a plus.
  • Ability to prioritize and multi-task projects independently is preferred.
  • Strong organizational, interpersonal and written/verbal communication skills are required