Regulatory Affairs Specialist II

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Regulatory Affairs Specialist II

  • Specialty:

    Professional
  • Title:

    Regulatory Affairs Specialist II
    • City:

      Milford
    • State:

      MA
    • Zip Code:

      01757
  • Start date:

    02-03-2020
  • Status:

    Closed
  • Assignment Type:

    Contract
  • Job Id:

    52223

Description

Seeking an experienced Regulatory Affairs Specialist for global Life Science company based out of Milford, MA. This is a long-term contract opportunity.

Responsibilities:

  • Participate as a core team member on new product development teams providing regulatory guidance.
  • Develop regulatory strategies for new and modified products
  • Preparing regulatory filings such as pre-Submissions, premarket notifications, technical files, Canadian submissions and letters to file
  • Perform regulatory research as needed
  • Review and approve promotional materials
  • Maintain global establishment registrations and device listings
  • Assist with filing field action reports and correspondence with regulatory agencies
  • Fulfill requests for documentation to support international regulatory submissions

Requirements/Qualifications:

  • Minimum of a Bachelor's degree, preferably within in science or engineering
  • 3-5 years’ experience in Medical Device environment
  • Industry experience within Clinical IVD highly desired
  • Previous experience preparing regulatory filings such as pre-Submissions, premarket notifications, & technical files for US & EU regulatory approval, preferably for clinical IVD products
  • Knowledge of 21 CFR 820 and ISO 13485 required
  • Knowledge of the US and European IVD regulations required
  • Knowledge of other international regulations a plus
  • Team player demonstrating good organizational and communication skills
  • Self-starting demonstrating initiative
  • Critical Thinking, Active Listening, and Technical Writing Skills required
  • RAC a Plus

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