Senior MedTech Regulatory Affairs Associate ANZ

J&J Family of Companies; Sydney; On-site; AUD 110,000 - 150,000; Full time

Benefits offered by this job

Parental leave (up to 18 weeks)

Volunteer leave

Wellbeing Day

Life insurance

Flexible working arrangements

Job summary

Johnson & Johnson MedTech is expanding its Regulatory Affairs team in Sydney. We seek a Senior Regulatory Affairs Associate to oversee registration, maintenance, and compliance of innovative medical technologies across Australia and New Zealand.

You will partner with cross-functional teams, manage submissions, respond to regulator requests, and drive process improvements to support market access and ongoing compliance.

Qualifications

• Minimum 3–5 years' regulatory experience in medical devices.
• Knowledge of regulatory frameworks and standards including TGA, Medsafe and ISO.
• Strong organisation and project management abilities with attention to detail.
• Proactive and consultative with the ability to work with cross-functional teams.
• Excellent written and verbal communication skills.

Responsibilities

• Preparing and submitting regulatory applications and documentation for ANZ market access.
• Maintaining regulatory registrations and responding to authority requests.
• Providing regulatory guidance to cross-functional teams during product development.
• Leading process improvements and best-practice regulatory initiatives.
• Building relationships with regulatory authorities and industry groups.

Skills

Regulatory affairs

Regulatory knowledge

Project management

Attention to detail

Cross-functional collaboration

Written and verbal communication

Education

Regulatory degree

Job description

Johnson & Johnson MedTech is expanding its Regulatory Affairs team in Sydney. We seek a Senior Regulatory Affairs Associate to oversee registration, maintenance, and compliance of innovative medical technologies across Australia and New Zealand.

You will partner with cross-functional teams, manage submissions, respond to regulator requests, and drive process improvements to support market access and ongoing compliance.