Senior Regulatory Specialist

Are you a Regulatory Affairs professional ready to step into a lead role within a global, innovation-driven medical device company?

This is a fantastic opportunity to join a well-established business recognised 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 key international markets, with a particular focus on APAC and EMEA regions. You’ll partner with cross-functional teams to drive product registrations, ensure compliance obligations are met, and support commercial initiatives.

Whether you're a seasoned Senior RA professional ready to step up, or an experienced lead seeking a new challenge, this position offers scope, visibility, and the chance to make a tangible impact in a truly global environment.

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 bbyrne@i-pharmconsulting.com OR (04) 21776703