Senior Regulatory Affairs Associate - MedTech, Sydney

Brighter Signals; Sydney; On-site; AUD 110,000 - 160,000; Full time

Benefits offered by this job

Parental leave up to 18 weeks

Volunteer leave

Wellbeing day

Life insurance

Employee Assistance Program

Flexible working arrangements

Job summary

Brighter Signals is seeking a Senior Regulatory Affairs Associate for MedTech in Sydney. You will lead regulatory submissions, maintain registrations and compliance for innovative medical devices across Australia and New Zealand.

Work with cross-functional teams to support product development, manage authority inquiries, and drive continuous improvement in regulatory processes to enable timely market access.

Qualifications

• 3–5 years of regulatory experience in medical devices.
• Knowledge of regulatory frameworks: TGA, Medsafe, ISO.
• Excellent written and verbal communication skills.

Responsibilities

• Prepare and submit regulatory applications and documentation for ANZ.
• Maintain product registrations and respond to authority requests.
• Provide regulatory guidance to cross-functional teams.
• Drive process improvements and best-practice adoption.
• Build and maintain relationships with authorities and stakeholders.

Skills

Regulatory submissions

Medical devices

Cross-functional collaboration

Project management

Detail-oriented

Education

Bachelor's degree in life sciences or related field

Tools

Regulatory databases

Job description

Senior Regulatory Affairs Associate - MedTech, Sydney

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-careGlobal 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.