Regulatory Affairs Specialist

AP Professionals
Published
August 8, 2018
Location
Rochester
Job Type

Description

6 month contract with a possible 6 month extension! $20 – 25/hour

Directly supporting the Global Regulatory Compliance Manager, the incumbent will be responsible for the evaluation of the product labeling process for improvement. Advise the Regional Regulatory team on global regulatory submissions as necessary. Work autonomously in a team environment. Previous experience in a heavy regulated industry or quality background is an absolute must!

Responsibilities

  • Generate regulatory assessment documents for product rebranding requests or projects.
  • Review, coordinate, and approve product labeling and marketing materials. Initiate new package inserts and other product labeling.
  • Evaluate product labeling and manufacturing changes for impact on global regulatory affairs approvals, clearances, registrations, and licenses.
  • Track global rollout of product approvals for product changes and updating labeling; provide updates to appropriate internal departments.
  • Develop, implement, and maintain global regulatory procedures to ensure regulatory compliance.
  • Train others on new and revised procedures and perform ongoing evaluations.
  • Support local regulatory in maintaining global regulatory submissions.
  • Maintain regulatory files and documents, and maintain interdepartmental communication to provide regulatory status reports.

Qualifications

  • Bachelor’s degree in a scientific or technical discipline required; regulatory affairs certification preferred.
  • 1-2 years’ related regulatory affairs experience in the medical device industry required.
  • Explicit knowledge of domestic and international regulations required; including 21 CFR 801 Labeling and ISO 11978.
  • MS Office Suite and Adobe Acrobat XPro proficiency required; experience with Esko preferred.
  • Ability to work in a multinational and multicultural environment required.
  • Strong problem solving, project management, and technical writing skills required.
  • Strong mathematical, analytical, and computer skills required.
  • Exceptional attention to detail required.
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