Senior Regulatory Affairs Associate - MedTech, Sydney

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

Fuelled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalised treatments.

Visit us at https://www.jnj.com/medtech to see how your unique talents will help patients on their journey to wellness.

The Opportunity

To support our continued growth, we’ve created a new opportunity for a Senior Regulatory Affairs Associate in Sydney. Reporting into the Regulatory Affairs Manager, you will play a key role in ensuring the successful registration, maintenance, and compliance of innovative medical technologies across Australia and New Zealand.

Responsibilities

• Preparing and submitting regulatory applications and documentation to support new product launches, product changes, and ongoing market access across ANZ
• Maintaining regulatory compliance by managing product registrations, responding to regulatory authority requests, and supporting periodic reporting requirements
• Providing regulatory guidance and expertise to cross-functional teams, supporting product development, business initiatives, and audit activities
• Driving continuous improvement by contributing to regulatory best practices, leading process enhancement initiatives, and supporting team capability development
• Building and maintaining effective relationships with regulatory authorities, industry groups, and internal stakeholders to support business objectives and regulatory outcomes

About You

• Degree qualified with minimum 3-5 years demonstrated experience in a regulatory role within medical devices
• Knowledge and understanding of regulatory frameworks and standards including TGA, Medsafe and ISO
• Strong organisation, project management and problem-solving abilities, with strong attention to detail
• Proactive with a consultative approach, and the capacity to engage and work with cross functional teams
• Excellent written and verbal communication skills, with the ability to communicate complex regulatory concepts effectively

Why Choose Us

• Competitive remuneration package
• Continuous training and support
• Inclusive, flexible, and accessible working arrangements
• Equal opportunity employer supporting diversity and inclusion
• Up to 18 weeks of parental leave to support new parents
• 4 days of volunteer leave to give back to the community
• Option to purchase up to 2 weeks of additional annual leave for extra time off
• Enjoy a dedicated Wellbeing Day to prioritise self-care
• Global Wellness Reimbursement of $780 per year for healthy eating, exercise, or mindfulness activities
• Access to an Employee Assistance Program for personal and professional support
• Enhanced leave provisions for compassionate (caregiver) leave, providing up to 30 days of additional support
• Life insurance coverage for added peace of mind

And much more...

All applicants must have rights to work in Australia.