Medical Devices Regulatory Compliance Specialist

3 days ago


Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €100,000
Job Overview

This role is responsible for leading the technical regulatory compliance of medical devices and drug-device combination products. The successful candidate will have a strong understanding of FDA, EU, and ISO standards, regulations, and guidance related to design control and regulatory compliance.


Key Responsibilities
  • Maintain awareness of current regulations and regulatory guidance in regions of interest to Viatris development programs.
  • Collaborate with the Technical Regulatory function and wider GDD on the development of regulatory strategies for combination products and medical devices.
  • Provide mentoring and support the development of the Technical Regulatory team.
  • Author and review documents for regulatory submissions including NDAs, ANDAs, BLAs, MAAs, variations, and other activities.

Requirements

The ideal candidate will possess:

  • A Bachelor's degree in a scientific or engineering discipline.
  • Proven experience in pharmaceutical and/or medical device development.
  • Advanced knowledge of global Medical Device and Drug-Device Combination Product regulatory requirements, regulatory plans, and high-level strategy planning.
  • Knowledge of global Medical Device and Drug-Device Combination Product quality requirements.
  • Demonstrable experience in multi-disciplinary teams within a pharmaceutical development environment.

What We Offer
  • Competitive salaries.
  • Excellent career progression opportunities.
  • Work-life balance initiatives.
  • Health insurance.
  • Pension.


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