Regulatory Affairs Strategist

1 day ago

Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €120,000 - €150,000
Job Overview

We are seeking a highly motivated Regulatory Affairs Strategist to lead and oversee all regulatory compliance activities.

Key Responsibilities:
  • Develop and execute regulatory strategies for new product introductions and post-market activities.
  • Manage global product registrations and ensure compliance with evolving regulatory requirements.
  • Serve as the primary contact for regulatory agencies, including authorities in the U.S. and Europe.
  • Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards.
  • Review and approve promotional and advertising materials from a regulatory perspective.
Candidate Requirements:
  • Bachelor's degree in Engineering, Life Sciences, or a health-related field.
  • 10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role.
  • In-depth knowledge of US FDA and EU medical device regulations (including MDR).
  • Proven ability to handle complex regulatory submissions and interactions.
  • Excellent organizational, leadership, and communication skills.
  • A self-starter with a hands-on approach and the ability to thrive in a dynamic environment.
About this Role

This is a critical leadership position that requires a strong understanding of regulatory affairs and the ability to drive business growth while ensuring compliance.

Why You'll Thrive Here

You will have the opportunity to work with a talented team of professionals who are passionate about innovation and regulatory excellence.

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