Senior Regulatory Affairs Associate - MedTech, Sydney

7515-Johnson & Johnson Medical Pty Ltd Legal Entity; Sydney; On-site; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive remuneration package

Training and development programs

Flexible working arrangements

Diversity and inclusion

Job summary

Johnson & Johnson in Sydney is seeking a Senior Regulatory Affairs Associate to lead regulatory submissions and maintain compliance for innovative medical technologies across Australia and New Zealand.

You will partner with cross-functional teams to support product development, navigate TGA, Medsafe, and ISO standards, and drive successful market access while contributing to process improvements and regulatory strategies.

Qualifications

• Degree in a life sciences field with regulatory experience in medical devices.
• Knowledge of regulatory frameworks including TGA, Medsafe and ISO.
• Strong organizational, project management and communication skills.

Responsibilities

• Prepare and submit regulatory applications and documentation for ANZ product registrations and changes.
• Maintain regulatory compliance and respond to regulator requests; support periodic reporting.
• Provide regulatory guidance to cross-functional teams and support product development and audits.
• Contribute to best practices and process improvements; support team capability development.
• Build relationships with regulatory authorities and internal stakeholders to achieve regulatory outcomes.

Skills

Regulatory knowledge

Project management

Documentation

Communication

Education

Bachelor's degree in Life Sciences

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
Job Location: 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.

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.