DermapenWorld | Belrose, Sydney | Hybrid working arrangements

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.

Amplify HR is partnering with DermapenWorld to recruit a Regulatory Affairs Officer, based at its Belrose head office with hybrid working arrangements.

About the role

Enjoy working with detail and helping products meet high standards? DermapenWorld is looking for a Quality Officer to support compliance across its medical device and cosmetics portfolios.

Based at the Belrose head office, with hybrid working arrangements, you’ll report directly to the General Counsel and work closely with colleagues across quality, marketing, manufacturing and global sales.

Your work will help ensure products meet regulatory requirements across Australia, the USA, the UK, the EU and other international markets.

What you’ll be doing

This is a varied, hands-on role combining documentation, product registrations and compliance support. You’ll:

Prepare, submit and maintain global product registrations, regulatory filings and notifications.

Maintain Unique Device Identification (UDI) databases, including GUDID and EUDAMED, and relevant TGA device records.

Keep technical files, safety reports, post-market surveillance records and change-control documentation accurate and current.

Review product information, labelling, packaging, artwork and marketing claims against regulatory requirements.

Provide international distributors with documentation, declarations and certificates for local market approvals.





Monitor regulatory changes and communicate their impact and required actions to colleagues.

Support internal, external and regulatory audits and inspections.

Help improve processes, documentation quality and compliance efficiency.

About you

You’re thorough, organised and comfortable working with technical information. You enjoy collaborating with others and can manage competing priorities while keeping deadlines on track.

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 review technical labelling and marketing claims against regulatory requirements.

Excellent written and verbal communication skills, including when working with regulators and international partners.

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 join DermapenWorld?

You’ll gain exposure to international markets across both medical devices and cosmetics. Working closely with a small team and directly with the General Counsel, you’ll contribute to product compliance and practical improvements across the business.

Hybrid working arrangements are available, with the role based at the Belrose head office.

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📌 Quality Officer (Sydney)
🏢 Amplify HR
📍 Sydney