Senior MedTech Regulatory Affairs Associate – ANZ

7515-Johnson & Johnson Medical Pty Ltd Legal Entity; Sydney; On-site; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive remuneration package

Training and development programs

Flexible working arrangements

Diversity and inclusion

Job summary

Johnson & Johnson in Sydney is seeking a Senior Regulatory Affairs Associate to lead regulatory submissions and maintain compliance for innovative medical technologies across Australia and New Zealand.

You will partner with cross-functional teams to support product development, navigate TGA, Medsafe, and ISO standards, and drive successful market access while contributing to process improvements and regulatory strategies.

Qualifications

• Degree in a life sciences field with regulatory experience in medical devices.
• Knowledge of regulatory frameworks including TGA, Medsafe and ISO.
• Strong organizational, project management and communication skills.

Responsibilities

• Prepare and submit regulatory applications and documentation for ANZ product registrations and changes.
• Maintain regulatory compliance and respond to regulator requests; support periodic reporting.
• Provide regulatory guidance to cross-functional teams and support product development and audits.
• Contribute to best practices and process improvements; support team capability development.
• Build relationships with regulatory authorities and internal stakeholders to achieve regulatory outcomes.

Skills

Regulatory knowledge

Project management

Documentation

Communication

Education

Bachelor's degree in Life Sciences

Job description

Johnson & Johnson in Sydney is seeking a Senior Regulatory Affairs Associate to lead regulatory submissions and maintain compliance for innovative medical technologies across Australia and New Zealand.

You will partner with cross-functional teams to support product development, navigate TGA, Medsafe, and ISO standards, and drive successful market access while contributing to process improvements and regulatory strategies.