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Senior Regulatory Affairs Professional (Director)

Company: Job Juncture
Location: Westwood
Posted on: September 22, 2019

Job Description:

This is a critical hire for our client and will be responsible for the global regulatory strategy of a new product. This is a hands-on role that will oversee regulatory submissions from planning stages through execution, preparing for global launch. In this role you'll adhere to timelines, budget, and quality, while working in a relatively autonomous, fast-paced role.

Senior Regulatory Affairs Professional (Director Level)Westwood, MA (Relocation Provided)DOE; $185-200K+, 10-15% bonus, 4 weeks Vacation, Full Benefits--What makes this role unique: A 10+ year client of ours has acquired an exciting technology company and is ramping up to commercialize the product; development, research, clinical, regulatory, etc - all of this ground-floor opportunities to create & build, but have the stability of working for a multi-billion dollar profitable business! Start-up feel, big-business backing and support. This role is within a leading medical diagnostic company, that offers cutting edge technology, machines, and rapid testing solutions at physicians' fingertips.----Requirements:Desired Qualifications:

  • Bachelor of Science required; in a technical capacity (Science based - strongly preferred, others will be considered based on overall relevant experience)
  • 8-15+ years of Regulatory Affairs experience; with experience in a medical device, medical instrument, or biotech industry (required)
  • Experience with U.S. FDA 510k and/or PMA submissions and interaction with FDA reviewers required.
  • Knowledge and experience with global registrations strongly preferred (EU, etc)
  • RAC (Regulatory Affairs Certification) desired, not required
  • Strong leadership, interpersonal, communication and organizational skills required.
  • Must possess a high level of critical and strategic thinking skills and be a detail oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities.
  • Must be able to set priorities as well as adapt to changing priorities

Keywords: Job Juncture, Fall River , Senior Regulatory Affairs Professional (Director), Executive , Westwood, Massachusetts

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