Regulatory Compliance Expert

2 weeks ago


Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €120,000
Key Responsibilities of Regulatory Affairs Manager
  • Define and Execute Regulatory Strategy: Develop regulatory strategies for products, ensuring compliance with US and EU regulations.
  • Lead Regulatory Filings: Oversee the preparation and submission of regulatory documents, including 510(k), CE mark submissions, product registrations, and interactions with regulatory agencies.
  • Build and Maintain Relationships: Establish and maintain strong relationships with regulatory bodies to ensure successful product approvals.
  • Monitor Regulatory Changes: Stay up-to-date with changing regulatory requirements and adapt company strategy accordingly.
  • Collaborate with Quality Assurance: Work with Quality Assurance on post-market surveillance and vigilance activities in Europe and the US.
  • Review and Approve Materials: Ensure that advertising and promotional materials comply with regulatory requirements.
  • Provide Strategic Guidance: Offer regulatory expertise to the leadership team, informing strategic decisions.
  • Manage Resources: Lead and develop resources within the regulatory function.

The ideal candidate will have a degree in Engineering, Science, or a health-related discipline, with significant experience in the medical device industry. They should possess proven leadership skills, excellent organisational abilities, and strong communication and interpersonal skills.



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