Senior Regulatory Specialist

3 weeks ago

Council of the City of Sydney, Australia i-Pharm ConsultingGruppe Full time

Overview

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.

- Permanent

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.

How to apply

Apply directly now, or send your updated CV to Ben Byrne at bbyrne@i-pharmconsulting.com OR (04) 21776703

- Location Melbourne, Victoria, Australia (Remote)

- Perth, Western Australia, Australia (On-site)

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