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 within the MedTech division to ensure market access and regulatory excellence.

Key responsibilities

• Prepare and submit regulatory applications and documentation for new product launches, product changes, and ongoing market access across ANZ.
• Maintain regulatory compliance by managing product registrations, responding to authority requests, and supporting periodic reporting.
• Provide regulatory guidance to cross‑functional teams, support product development, business initiatives, and audit activities.
• Drive continuous improvement by contributing to best practices, leading process enhancements, and supporting team capability development.
• Build and maintain effective relationships with regulatory authorities, industry groups, and internal stakeholders.

Required profile

• Degree qualified with 3‑5 years of regulatory experience in medical devices.
• Strong organisational, project‑management and problem‑solving abilities with high attention to detail.
• Proactive, consultative approach with ability to work across cross‑functional teams.
• Excellent written and verbal communication skills to convey complex regulatory concepts.

Required skills

• Knowledge of TGA (Therapeutic Goods Administration) regulations.
• Knowledge of Medsafe (New Zealand) regulations.
• Familiarity with ISO standards for medical devices.

What we offer

• Competitive remuneration package.
• Continuous training and support, including award‑winning leadership development programs.
• Inclusive, flexible, and accessible working arrangements.
• Up to 18 weeks of parental leave, 4 days of volunteer leave, and option to purchase additional annual leave.
• Dedicated Wellbeing Day, global wellness reimbursement of $780 per year, and employee assistance program.