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Regulatory Affairs Assistant - Junior

  • Job reference: 923417
  • Location: Leeds, West Yorkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 17/01/2019

Orion Group are recruiting for a Regulatory Specialist on behalf of our Multinational Medical Device Client on an initial 6 month contract based in the West Yorkshire Area


  • 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.
  • 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 labelling, and promotional materials.
  • Defines data and information needed for regulatory approvals.
  • Develops labelling specifications and approves proposed labelling, 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.

Functional and Technical Competencies:

  • Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products.
  • Tactical and strategic regulatory knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class II and III devices (EU and USA).
  • Ability to partner and influence key stakeholders on NPD and Lifecycle teams.


  • BS with minimum 6 years of experience or equivalent
  • 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), advantageous.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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