European Regulatory Affairs Lead

2 weeks ago


Athlone, County Westmeath, Ireland beBeeRegulatoryAffairsManager Full time €80,000 - €100,000

We are a global provider of medical technologies aiming to improve healthcare and quality of life through our vision to become the most trusted partner in this field.

Job Overview:

This role is responsible for leading regulatory affairs across Europe, Middle East, and Africa. The successful candidate will oversee regional regulatory strategies, product registrations, and notifications.

  • Ensure regulatory compliance by driving cross-functional collaboration and supporting business objectives.

The ideal candidate will have

  • a minimum 5-7 years' experience in a similar role with a medical device background.
  • a degree in Regulatory, Biomedical Engineering or Science related discipline.
  • a strong understanding of relevant regulations and guidelines.
  • excellent verbal and written communication skills.
  • ability to manage multiple projects and deadlines effectively.
Key Responsibilities:
  • Provide strategic leadership and oversight for the International Regulatory Affairs team.
  • Serve as the designated delegate for the Person Responsible for Regulatory Compliance (PRRC).
  • Ensure that all products, processes, and documentation comply with relevant global regulatory requirements.
  • Develop, implement, and refine regulatory strategies for new and existing products.

This role requires strong collaboration and influencing skills, excellent communication skills, and goal orientation for customer and business objectives.

Please note that due to the dynamic nature of our business, key responsibilities will evolve and change over time.



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