Senior Regulatory Affairs Associate - MedTech, Sydney

Benjaminx; Sydney; Hybrid; AUD 110,000 - 140,000; Full time

Benefits offered by this job

Parental leave

Volunteer leave

Wellbeing benefits

Life insurance

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Associate to support registrations, maintenance, and compliance for innovative medical technologies across Australia and New Zealand. Reporting to the Regulatory Affairs Manager, you will drive submissions and ongoing regulatory activities to enable new product launches and lifecycle management.

The role requires a degree with 3–5 years in regulatory affairs within medical devices, familiarity with TGA, Medsafe and ISO standards, and

Qualifications

• 3–5 years of demonstrated experience in regulatory roles within medical devices.
• Knowledge of regulatory frameworks and standards including TGA, MedSafe and ISO.
• Strong written and verbal communication with ability to convey complex regulatory concepts.

Responsibilities

• Prepare and submit regulatory applications and documentation to support product launches, changes and market access across ANZ.
• Maintain regulatory registrations and respond to authority requests; support periodic reporting.
• Provide regulatory guidance to cross-functional teams and support audits and product development.
• Contribute to process improvements and regulatory best practices.

Skills

Regulatory submissions

Regulatory strategy

Regulatory compliance

Cross-functional collaboration

Project management

Education

Degree in a relevant field

Job description

## About this opportunityAt 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 ANZMaintaining regulatory compliance by managing product registrations, responding to regulatory authority requests, and supporting periodic reporting requirementsProviding regulatory guidance and expertise to cross-functional teams, supporting product development, business initiatives, and audit activitiesDriving continuous improvement by contributing to regulatory best practices, leading process enhancement initiatives, and supporting team capability developmentBuilding 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 devicesKnowledge and understanding of regulatory frameworks and standards including TGA, Medsafe and ISOStrong organisation, project management and problem-solving abilities, with strong attention to detailProactive with a consultative approach, and the capacity to engage and work with cross functional teamsExcellent written and verbal communication skills, with the ability to communicate complex regulatory concepts effectively**Why Choose Us**Competitive remuneration packageContinuous training and supportAward-winning leadership development programsInclusive, flexible, and accessible working arrangementsEqual opportunity employer supporting diversity and inclusion**Our Benefits**Up to 18 weeks of parental leave to support new parents4 days of volunteer leave to give back to the communityOption to purchase up to 2 weeks of additional annual leave for extra time offEnjoy a dedicated Wellbeing Day to prioritise self-careGlobal Wellness Reimbursement of $780 per year for healthy eating, exercise, or mindfulness activitiesAccess to an Employee Assistance Program for personal and professional supportEnhanced leave provisions for compassionate (caregiver) leave, providing up to 30 days of additional supportLife insurance coverage for added peace of mindAnd much more...All applicants must have rights to work in Australia.