Senior Regulatory Affairs Associate (MedTech)

Location: North Ryde, New South Wales, Australia. All applicants must have the right to work in Australia.

Company

Johnson & Johnson MedTech develops smarter, less invasive, and more personalised medical technologies.

What you will do

• Prepare and submit regulatory applications and documentation for new product launches, product changes, and ongoing market access across Australia and New Zealand.
• Maintain product registrations, respond to regulatory authority requests, and support periodic reporting requirements.
• Provide regulatory guidance to product development, business, audit, and other cross-functional initiatives.
• Drive regulatory best-practice and process-improvement initiatives while supporting team capability development.
• Build relationships with regulatory authorities, industry groups, and internal stakeholders.

Requirements

• Degree qualification and 3–5 years of experience in a regulatory role within medical devices.
• Knowledge of Australian and New Zealand regulatory frameworks, including TGA, Medsafe, and ISO standards.
• Strong organisation, project management, problem-solving, and attention-to-detail skills.
• Consultative approach and ability to work effectively with cross-functional teams.
• Excellent written and verbal communication skills, including the ability to explain complex regulatory concepts.
• Right to work in Australia.

Culture & Benefits

• Inclusive, flexible, and accessible working arrangements.
• Continuous training and support.
• Leadership development programs.
• Up to 18 weeks of parental leave and four days of volunteer leave.
• Option to purchase up to two weeks of additional annual leave and access to a dedicated Wellbeing Day.
• Global wellness reimbursement of $780 per year, an Employee Assistance Program, enhanced compassionate leave, and life insurance.