Regulatory Affairs Program Manager

4 weeks ago

Boston, United States firstPRO, Inc Full time

FirstPro is now accepting resumes for a Regulatory Affairs Program Manager position based in Boston, MA. This role will focus on handling regulatory affairs requirements for medical devices, biologic and products by developing regulatory strategies and regulatory submissions for new and modified products both domestically and international regulatory bodies. This is a permanent, direct-hire role that can offer benefits and a hybrid working schedule.


Responsibilities

  • Working closely with process development, manufacturing and quality departments to support the preparation of domestic and international regulatory submissions. This includes writing, reviewing, and editing technical reports and regulatory documentation.
  • Providing input on and review of protocols and reports including but not limited to process validation, equipment qualification, and shelf-life studies.
  • Ensuring regulatory compliance with QSR and cGMP requirements and stay apprised of ICH, FDA and EU requirements.
  • Evaluating changes to determine the filing requirements and impact on AATB certifications, state licenses, and FDA registrations.
  • Review of labeling changes, and advertising and promotional material.
  • Review of complaints for medical device reporting (MDR) requirements.
  • This individual will also provide regulatory support and guidance for product changes to US marketed products.


Requirements

  • 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.
  • 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.

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