Senior Regulatory Affairs Associate – MedTech

About the role

Johnson & Johnson is seeking a Senior Regulatory Affairs Associate to support the registration, maintenance, and compliance of innovative medical technologies across Australia and New Zealand. Reporting to the Regulatory Affairs Manager, you will work closely with cross‑functional teams to ensure market access and regulatory excellence.

Key responsibilities

• Prepare and submit regulatory applications and documentation for new product launches, changes, and ongoing market access in ANZ.
• Maintain product registrations, respond to authority queries, and support periodic reporting requirements.
• Provide regulatory guidance to product development and business initiatives, and support audit activities.
• Drive continuous improvement by contributing to best‑practice processes and team capability development.
• Build and maintain relationships with regulatory authorities, industry groups, and internal stakeholders.

Required profile

• Degree qualified with 3‑5 years of regulatory experience in medical devices.
• Strong knowledge of TGA, Medsafe and ISO standards.
• Excellent project management, problem‑solving, and attention to detail.
• Proactive, consultative approach with ability to work across functions.
• Strong written and verbal communication skills.

Required skills

• TGA regulatory framework
• Medsafe regulatory framework
• ISO standards for medical devices

What we offer

• Competitive remuneration package
• Continuous training and leadership development programs
• Inclusive, flexible working arrangements
• Up to 18 weeks parental leave, volunteer leave, and additional annual leave purchase
• Wellbeing Day, $780 wellness reimbursement, Employee Assistance Program
• Life insurance and enhanced compassionate leave