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Research Associates II
Ref No.: 18-01152
Location: Raynham, Massachusetts
Start Date / End Date: 02/02/2018 to 02/02/2019
Role Responsibilities and Activities such as but not limited to:
  • Serves as a consultant and technical expert on Regulatory Affairs matters.
  • Provides assistance in preparation and submission of global regulatory documents.
  • Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Inclusive of site transfer activities.
  • Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
  • Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
  • Defines data and information needed for regulatory approvals.
  • Develops labeling specifications and approves proposed labeling, packaging, advertising, and promotional materials after evaluating conformance to regulations.
  • Provide Regulatory Affairs support during internal and external audits.
  • Plans schedules for regulatory deliverables on a project and monitors project through completion.
  • Assists in the development of best practices for Regulatory Affairs processes.
  • Represents Regulatory Affairs on cross-functional project teams.
  • Partners with other functions to define and obtain data to assist with regulatory submissions.
  • Minimum of a B.A. /B.S. within a technical related discipline is required.
  • Minimum 3-5 years relevant / regulated industry experience is required. Previous experience with medical devices is strongly preferred.
  • Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required.
  • Leadership experience is required.
  • Ability to work both independently and in a team environment. Ability to problem solve, recognize and find solutions for gaps in processes.