We are currently working with a client in the medical device sector who is seeking an experienced
Regulatory Affairs Manager
to 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 Role
As
Regulatory 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 Responsibilities
* Define 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 For
* Degree 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.