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 GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
North Ryde, New South Wales, AustraliaJob 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.
Required Skills:
Preferred Skills:
Skills Required
- Degree qualification
- Minimum 3–5 years of experience in a regulatory role within medical devices
- Knowledge of regulatory frameworks and standards including TGA, Medsafe, and ISO
- Strong organization, project management, and problem-solving abilities
- Strong attention to detail
- Proactive, consultative approach with the ability to work cross-functionally
- Excellent written and verbal communication skills, including communicating complex regulatory concepts
- Rights to work in Australia
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
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