Senior Regulatory Affairs Expert

5 days ago

Galway, Galway, Ireland beBeeMedical Full time €100,000 - €120,000
Regulatory Affairs Manager

This critical leadership role oversees all regulatory compliance activities, defining and executing strategies for new product development and post-market activities.

The ideal candidate will have a strong background in medical device regulations, including MDR, and proven ability to handle complex submissions and interactions.

A self-starter with excellent organizational, leadership, and communication skills is required to thrive in a dynamic environment.

Key Responsibilities
  • Lead the regulatory strategy for new product introductions and support existing products through their full lifecycle.
  • Manage regulatory submissions (e.g. 510(k), CE Mark) and global product registrations.
  • Act as the primary contact for regulatory agencies, including authorities in the U.S. and Europe.
  • Monitor and interpret evolving regulatory requirements and apply them to ensure company compliance.
  • Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards.
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.
  • Proven ability to handle complex regulatory submissions and interactions.
  • Excellent organizational, leadership, and communication skills.
  • A self-starter with hands-on approach and ability to thrive in a dynamic environment.

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