At a Glance
- Tasks: Ensure compliance and registration of innovative medical technologies across Australia and New Zealand.
- Company: Join a leading MedTech company focused on innovation and patient wellness.
- Benefits: Competitive pay, flexible work, wellness support, and generous leave options.
- Other info: Inclusive culture with opportunities for professional growth and community engagement.
- Why this job: Make a real impact in healthcare by supporting groundbreaking medical advancements.
- Qualifications: 3-5 years in regulatory affairs with knowledge of TGA and Medsafe standards.
The predicted salary is between 82800 - 101200 $ per year.
Fuelled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalised treatments. 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.
Senior Regulatory Affairs Associate – Sydney employer: Brighter Signals
At Johnson & Johnson, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work environment that fosters personal and professional growth. As an Area Manager in the vibrant regions of New South Wales, Queensland, and New Zealand, you will benefit from competitive remuneration, extensive training programs, and a strong commitment to employee wellbeing, including generous parental leave and wellness reimbursements. Join us in making a meaningful impact on healthcare while enjoying a culture that values diversity, collaboration, and innovation.
