Regulatory Affairs Manager

2 days ago

Galway, Ireland Amfconsulting Full time

We are currently working with a client in the medical device sector who is seeking an experiencedRegulatory Affairs Managerto join their team in Galway.This is a fantastic opportunity to play a key role in shaping regulatory strategy and ensuring successful product approvals for innovative medical technologies.The RoleAsRegulatory Affairs Manager, you will be responsible for driving regulatory compliance activities, leading submissions, and building strong relationships with regulatory bodies.The role requires a mix of regulatory expertise, leadership, and a hands-on approach.Key ResponsibilitiesDefine and execute regulatory strategy for new and existing products.Lead regulatory filings including 510(k), CE mark submissions, product registrations, and regulatory interactions.Build and maintain strong relationships with the FDA, Notified Bodies, and other regulatory agencies.Monitor regulatory changes and adapt company strategy accordingly.Collaborate with Quality Assurance on post-market surveillance and vigilance activities in Europe and the US.Review and approve advertising and promotional materials from a regulatory standpoint.Provide strategic regulatory guidance to the wider leadership team.Manage and develop resources within the regulatory function.What We're Looking ForDegree in Engineering, Science, or a health-related discipline.10+ years' experience in the medical device industry, including at least 3 years in a management role.Strong knowledge of US and EU regulatory requirements (510(k), CE Mark, FDA, Notified Body interactions).Proven leadership, coaching, and mentoring skills.Excellent organisational, problem-solving, and prioritisation abilities.Strong communication and interpersonal skills.Experience in an SME or start-up environment is an advantage.A proactive, hands-on mindset.

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