Benefits

• Attractive salary package + completion bonus
• Flexible working hours + 2 days WFH after onboarding
• Additional perks including birthday leave, wellbeing days, onsite parking
• Fresh coffee available onsite and regular team lunches
• Join a collaborative and growing ANZ team within a global MedTech organisation

About the Company
Our client is a globally recognised medical technology organisation specialising in surgical devices and implantable technologies used across a range of surgical disciplines. With a long-standing international presence, the company partners with healthcare professionals worldwide to deliver innovative solutions that support improved patient outcomes.
The Australian business operates as part of a broader APAC network, working closely with global regulatory and quality teams to maintain product registrations and ensure ongoing compliance across markets. The organisation is known for its collaborative and supportive culture, offering employees the opportunity to work closely across departments while contributing to the delivery of high-quality medical technologies.

About the Opportunity
This Regulatory Affairs & Quality Officer position is a 12-month maternity leave contract based in Sydney’s Lower North Shore.

Reporting into the Senior Director, APAC, the role will support regulatory, quality and reimbursement activities across a portfolio of surgical medical devices. The position will primarily focus on maintaining regulatory approvals and ensuring ongoing compliance for products registered with the Therapeutic Goods Administration (TGA).

Working within a small and collaborative team, the successful candidate will have exposure across the regulatory lifecycle while supporting internal stakeholders across quality, commercial and global regulatory functions.

This opportunity is ideal for a regulatory professional with medical device experience who enjoys working in a hands-on role with strong exposure to regulatory authorities and cross-functional teams.

Duties

• Prepare and submit regulatory documentation to support TGA product registrations
• Maintain ARTG listings and manage lifecycle regulatory activities
• Respond to regulatory authority queries and support ongoing compliance requirements
• Maintain quality system documentation and support QMS processes
• Assist with reimbursement submissions and tender documentation where required
• Collaborate with internal teams including commercial, supply chain and global regulatory teams
• Support post-market activities including regulatory updates and compliance monitoring

Skills and Experience

• Experience in Regulatory Affairs within the medical device industry
• Exposure to TGA submissions and ARTG maintenance
• Experience across Class II or Class III devices and QMS processes
• Strong attention to detail and ability to collaborate with cross-functional teams

Culture
The organisation offers a collaborative and close-knit team environment, where employees work closely across regulatory, quality and commercial teams. With a growing presence in the ANZ market, the company encourages initiative and values individuals who take ownership of their work while contributing to a supportive team culture.

How to Apply
Click apply or contact Jenn Bowder, Senior Recruitment Consultant on 02 8877 8702 for a confidential discussion.

About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care.

• Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific;
• Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs;
• Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse;
  Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.