Medical Device Regulatory Strategist

5 days ago

Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €125,000
Regulatory Affairs Manager

Our organization is seeking a highly motivated Regulatory Affairs Manager to lead and oversee all regulatory compliance activities. This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities.

As the primary contact for regulatory agencies, including authorities in the U.S. and Europe, you will be responsible for monitoring and interpreting evolving regulatory requirements and applying them to ensure company compliance.

You will partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards and review and approve promotional and advertising materials from a regulatory perspective.

  • 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.
  • Review and approve promotional and advertising materials from a regulatory perspective.
  • Identify and allocate internal and external resources needed to maintain a robust regulatory function.
  • Provide strategic advice and cross-functional support on all regulatory matters.
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, entrepreneurial environment.
  • Previous experience in an SME or medtech startup is highly desirable.

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