Senior MedTech Regulatory Affairs Lead – ANZ

Johnson Johnson; Sydney; On-site; AUD 110,000 - 140,000; Full time

Benefits offered by this job

Parental leave (up to 18 weeks)

Volunteer leave (4 days)

Wellbeing Day

Life insurance

Job summary

Johnson & Johnson in Sydney seeks a Senior Regulatory Affairs Associate to support registration, maintenance and compliance of innovative medical technologies across Australia and New Zealand. Reporting to the Regulatory Affairs Manager, you will guide teams through regulatory pathways and liaise with authorities to ensure timely market access.

You will work with cross-functional teams to prepare submissions, respond to inquiries, and drive best practices in regulatory compliance while

Qualifications

• 3–5 years of regulatory experience in medical devices.
• Knowledge of regulatory frameworks including TGA, Medsafe and ISO.
• Strong organisational and project management abilities.
• Proactive with a consultative approach and cross-functional engagement.
• Excellent written and verbal communication skills.

Responsibilities

• Prepare and submit regulatory applications and documentation for ANZ product launches and regulatory changes.
• Maintain regulatory compliance by managing registrations, responding to authority requests, and supporting reporting.
• Provide regulatory guidance to cross-functional teams supporting development and audits.
• Drive continuous improvement by leading regulatory process enhancements and team capability development.
• Build and maintain relationships with regulatory authorities and industry groups.

Skills

Regulatory knowledge

Organisational skills

Project management

Cross-functional collaboration

Written and verbal communication

Education

Degree in a relevant field

Job description

Johnson & Johnson in Sydney seeks a Senior Regulatory Affairs Associate to support registration, maintenance and compliance of innovative medical technologies across Australia and New Zealand. Reporting to the Regulatory Affairs Manager, you will guide teams through regulatory pathways and liaise with authorities to ensure timely market access.

You will work with cross-functional teams to prepare submissions, respond to inquiries, and drive best practices in regulatory compliance while