Regulatory Specialist

Recruiter
Elevate Direct
Location
Leeds
Salary
35.00 - 40.00 GBP Hourly
Posted
13 Aug 2019
Closes
27 Aug 2019
Contract Type
Contract/Interim
Hours
Full Time

Serves as a consultant and technical expert on Regulatory Affairs matters. Under little to no supervision: provides assistance in preparation and submission of global regulatory documents.

POSITION DUTIES & RESPONSIBILITIES:

  • 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.

EDUCATION & EXPERIENCE REQUIREMENTS:

  • Degree with relevant experience
  • Practical experience with the preparation and submissions for Class II and III medical devices (EU and USA)
  • Substantial experience of US, EU and International Regulations required. Knowledge of International Regulations in China, Japan, Brazil and Russia preferred.
  • Knowledge of Additive manufacturing technology and associated regulations (Software)

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