Medical Device Regulatory Compliance Manager

3 days ago

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

Regulatory Affairs Director



The Regulatory Affairs Director will play a pivotal role in leading and overseeing all regulatory compliance activities for a fast-growing medical device company based in the West of Ireland. This leadership position will define and execute regulatory strategies in support of new product development and post-market activities.

Key Responsibilities:
  • Develop and implement regulatory frameworks for new product introductions and existing products through their full lifecycle.
  • Manage regulatory submissions, including 510(k) and CE Mark, and global product registrations.
  • Act as primary liaison for regulatory agencies, including US and European authorities.
  • Monitor and interpret evolving regulatory requirements to 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 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.
  • 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.

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