Senior MedTech Regulatory Affairs Lead, ANZ

Johnson & Johnson Innovative Medicine; Sydney; On-site; AUD 120,000 - 160,000; Full time

Benefits offered by this job

Parental leave (up to 18 weeks)

Volunteer leave (4 days)

Wellbeing Day

Global Wellness Reimbursement

Life insurance

Job summary

Johnson & Johnson is hiring a Senior Regulatory Affairs Associate in Sydney. You will support registration, maintenance, and compliance of innovative medical technologies across Australia and New Zealand, reporting to the Regulatory Affairs Manager.

Responsibilities include preparing regulatory submissions, maintaining registrations, guiding cross-functional teams, and driving process improvements to ensure regulatory outcomes. All applicants must have rights to work in Australia.

Qualifications

• Degree-qualified with 3–5 years in regulatory roles for medical devices.
• Knowledge of regulatory frameworks and standards including TGA, Medsafe and ISO.
• Strong organisational, project management and problem-solving abilities.
• Proactive with a consultative approach and cross-functional collaboration.
• Excellent written and verbal communication skills.

Responsibilities

• Prepare and submit regulatory applications and documentation for ANZ launches and ongoing market access.
• Maintain regulatory registrations and respond to authority requests.
• Provide regulatory guidance to cross-functional teams supporting development and audits.
• Drive process improvements and regulatory best practices.
• Build relationships with regulatory authorities and industry groups.

Skills

Regulatory affairs

Regulatory writing

Cross-functional collaboration

Project management

Attention to detail

Education

Bachelor's degree in a related field

Job description

Johnson & Johnson is hiring a Senior Regulatory Affairs Associate in Sydney. You will support registration, maintenance, and compliance of innovative medical technologies across Australia and New Zealand, reporting to the Regulatory Affairs Manager.

Responsibilities include preparing regulatory submissions, maintaining registrations, guiding cross-functional teams, and driving process improvements to ensure regulatory outcomes. All applicants must have rights to work in Australia.