Senior Regulatory Affairs Associate - MedTech, Sydney

Johnson & Johnson Innovation; Sydney; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

18 weeks parental leave

4 days volunteer leave

Wellbeing Day

Life insurance

Employee Assistance Program

Global Wellness Reimbursement

Job summary

Johnson & Johnson Innovation in Sydney is seeking a Senior Regulatory Affairs Associate to support regulatory registration, maintenance and compliance of innovative medical technologies across Australia and New Zealand. You will report to the Regulatory Affairs Manager and collaborate with cross-functional teams.

This role focuses on preparing regulatory applications, managing registrations, providing guidance, and driving process improvements to achieve timely market access while upholding

Qualifications

• 3–5 years regulatory experience in medical devices.
• Knowledge of regulatory frameworks including TGA, Medsafe and ISO.
• Strong organisational and project management skills with attention to detail.
• Proactive, consultative, and able to engage cross-functional teams.
• Excellent written and verbal communication of complex regulatory concepts.

Responsibilities

• Prepare and submit regulatory applications for ANZ launches and changes.
• Maintain registrations, respond to regulatory authority requests, and support reporting.
• Provide regulatory guidance to cross-functional teams.
• Lead process improvements and capability development within the team.
• Build relationships with regulatory authorities and internal stakeholders.

Skills

Organisation

Project management

Problem-solving

Attention to detail

Cross-functional collaboration

Communication skills

Education

Degree in a relevant field

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

North Ryde, New South Wales, Australia

Job Description:

About MedTech

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
• Award-winning leadership development programs
• Inclusive, flexible, and accessible working arrangements
• Equal opportunity employer supporting diversity and inclusion

Our Benefits

• 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.