Medical Device Regulatory Specialist

2 weeks ago

Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €120,000

Regulatory Affairs Leader

We are seeking an experienced Regulatory Affairs Manager to lead and oversee all regulatory compliance activities for our client.

Key Responsibilities:
  • Develop and execute regulatory strategies to support new product development and post-market activities.
  • Manage regulatory submissions and global product registrations.
  • Serve as the primary contact for regulatory agencies, including authorities in the U.S. and Europe.
  • Monitor and interpret evolving regulatory requirements and ensure company compliance.
  • Collaborate 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 resources needed to maintain a robust regulatory function.
  • Provide strategic advice on all regulatory matters.
Required Skills and Qualifications:
  • Bachelor's degree in Engineering, Life Sciences, or a health-related field.
  • At least 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 ability to thrive in a dynamic environment.

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