DermapenWorld | Belrose, Sydney | Hybrid working arrangements

Support global regulatory compliance across DermapenWorld’s medical device and cosmetics portfolios.

DermapenWorld’s medical device and cosmetics portfolios reach markets across Australia and internationally. Its regulatory team plays an essential part in ensuring products meet the requirements of each market, both before launch and throughout their lifecycle.

About the role

Reporting to the General Counsel, you’ll coordinate regulatory filings, maintain technical documentation and support compliance across Australia, the USA, the UK, the EU and other international markets.

Working closely with a small team and colleagues across quality, marketing, manufacturing and sales, you’ll help keep product registrations current, documentation accurate and product information compliant.

Your responsibilities will include:

- Preparing, submitting and maintaining product registrations, regulatory filings and notifications for medical devices and cosmetics.
- Maintaining Unique Device Identification (UDI) databases, including GUDID and EUDAMED, and relevant TGA device records.
- Managing technical files, safety reports, post-market surveillance records and change-control documentation.
- Reviewing product information, artwork, labelling, packaging and marketing claims against regulatory requirements.
- Providing international distributors with documentation, declarations and certificates to support local market approvals.
- Monitoring regulatory changes and advising colleagues on their impact and required actions.
- Supporting internal, external and regulatory audits and inspections.




- Improving regulatory processes and the quality of documentation.

About you

You enjoy working with detail and can turn complex requirements into clear, practical actions. You’re comfortable managing competing deadlines and building effective relationships with colleagues, regulators and international partners.

You’ll bring:

- Demonstrated experience in regulatory affairs or legal administration, preferably within medical devices, pharmaceuticals or cosmetics.
- Foundational knowledge of global regulatory requirements, including TGA (ARTG), FDA (510k/PMA) and EU MDR/IVDR.
- Experience maintaining UDI databases and managing technical documentation.
- Robust document control skills and proficiency with electronic Quality Management Systems (eQMS).
- Analytical skills and the ability to assess technical labelling and marketing claims against regulatory requirements.
- Excellent written and verbal communication skills.
- Strong organisational skills and the ability to manage multiple projects and regulatory deadlines.
- Tertiary qualifications in Law, Science, Biomedical Engineering or a related discipline will be highly regarded.

Why consider this opportunity?

This role offers exposure to a range of international regulatory frameworks across both medical devices and cosmetics. You’ll work directly with the General Counsel, collaborate with teams across the business and contribute to improvements in how regulatory work gets done.

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