Senior Regulatory Affairs Associate, MedTech – Sydney ANZ

Johnson & Johnson MedTech; 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

Wellness reimbursement $780/year

Employee assistance program

Job summary

Johnson & Johnson MedTech in Sydney is seeking a Senior Regulatory Affairs Associate to support registration, maintenance and compliance of medical technologies across Australia and New Zealand. Reporting to the Regulatory Affairs Manager, you will work with cross-functional teams to ensure timely submissions and ongoing market access.

We value proactive regulatory expertise, strong communication, and the ability to drive process improvements and audits.

Qualifications

• 3–5 years demonstrated experience in regulatory role within medical devices.
• Knowledge of regulatory frameworks and standards including TGA, Medsafe and ISO.
• Strong organisation, project management and problem solving abilities.
• Proactive with a consultative approach and ability to engage cross functional teams.
• Excellent written and verbal communication skills.

Responsibilities

• Preparing and submitting regulatory applications and documentation across ANZ.
• Maintaining regulatory compliance by managing product registrations and reporting requirements.
• Providing regulatory guidance to cross-functional teams and supporting audits.
• Driving continuous improvement by contributing to regulatory best practices and process enhancement.
• Building relationships with regulatory authorities and internal stakeholders to support regulatory outcomes.

Skills

Regulatory affairs

Medical devices

Project management

Communication

Problem solving

Education

Bachelor's degree in a relevant field

Job description

Johnson & Johnson MedTech in Sydney is seeking a Senior Regulatory Affairs Associate to support registration, maintenance and compliance of medical technologies across Australia and New Zealand. Reporting to the Regulatory Affairs Manager, you will work with cross-functional teams to ensure timely submissions and ongoing market access.

We value proactive regulatory expertise, strong communication, and the ability to drive process improvements and audits.