Are you a Regulatory Affairs professional ready to step into a lead role within a global, innovation-driven medical device company? This is a great opportunity to join a well-established business known for its strong culture and high-quality products used in healthcare settings worldwide. In this role, you’ll take the lead on regulatory activities across international markets, working closely with cross-functional teams to support product registrations, compliance obligations, and commercial initiatives. Whether you're currently a Senior RA professional ready to step up, or an experienced lead looking for a new challenge, this position offers scope, visibility, and the chance to make a tangible impact.

Responsibilities:

Lead and coordinate regulatory submissions, renewals, and product lifecycle activities to maintain market access across multiple international regions.

Manage post-market compliance obligations, either directly or in partnership with local representatives.

Provide timely regulatory input to support commercial initiatives such as tenders, product launches, and market expansion plans.

Act as the regulatory point of contact during audits and inspections from relevant authorities and certification bodies.

Keep internal stakeholders informed of changing regulatory requirements across supported markets, ensuring alignment with global regulatory strategies.

Collaborate on the review and approval of customer-facing materials, including marketing collateral and digital content.

Contribute to the continuous improvement of internal regulatory processes and systems.

Operate in compliance with internal quality procedures and contribute to the ongoing development of quality standards.

Skills:

Tertiary qualifications in Regulatory Affairs, Engineering, Science, or a related discipline.

Strong stakeholder engagement skills, with the ability to collaborate effectively across commercial, marketing, and senior leadership teams.

Confident communicator when working with external regulatory bodies, notified bodies, consultants, and third-party representatives.

3 - 5 years experience working with medical device regulations in APAC & EMEA markets.

Apply directly now, or send your updated CV to Ben Byrne at [email protected] OR (04) 21776703