Senior Regulatory Specialist
3 weeks ago
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.
Base pay rangeA$140,000.00/yr - A$150,000.00/yr
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.
- 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
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