Regulatory Affairs Assistant Manager - ANZ, MedTech

Brighter Signals; Sydney; On-site; AUD 120,000 - 155,000; Full time

Benefits offered by this job

Up to 18 weeks parental leave

Volunteer leave (4 days)

Additional annual leave option

Wellbeing Day

Global Wellness Reimbursement

Employee Assistance Program

Compassionate leave provisions

Life insurance

Job summary

Johnson & Johnson is seeking an Assistant Manager, Regulatory Affairs ANZ to lead regulatory activities across Australia and New Zealand. You will mentor a team of regulatory professionals, engage with agencies and associations, and drive lifecycle management for medical devices and MedTech solutions.

The role requires a scientific degree with 6–8 years of related experience, strong regulatory expertise, and willingness to travel up to ~10%.

Qualifications

• Bachelor's degree in a scientific discipline required; Master's preferred.
• Extensive knowledge of regional government regulations for medical devices.
• Ability to influence policy with regulators and industry partners.

Responsibilities

• Direct growth, post-marketing lifecycle management including labeling and copy clearance.
• Lead regulatory strategies and submissions to health authorities with ongoing compliance.
• Partner with regulators and trade associations to influence policy and resolve issues.
• Anticipate regulatory risks and drive best-practice policies and SOPs.
• Develop and lead the team, manage department budget and strategic direction.

Skills

Analytical Reasoning

Business Writing

Coaching

Collaboration

Communication

Legal Support

Problem Solving

Product Licensing

Public Policies

Regulatory Affairs Management

Regulatory Compliance

Regulatory Development

Regulatory Environment

Regulatory Reporting

Risk Assessments

Strategic Thinking

Education

Bachelor's degree in a scientific discipline

Master's degree (preferred)

Job description

Johnson & Johnson is seeking an Assistant Manager, Regulatory Affairs ANZ to lead regulatory activities across Australia and New Zealand. You will mentor a team of regulatory professionals, engage with agencies and associations, and drive lifecycle management for medical devices and MedTech solutions.

The role requires a scientific degree with 6–8 years of related experience, strong regulatory expertise, and willingness to travel up to ~10%.