Regulatory Affairs Lead, ANZ – MedTech Innovation

Narooma; Sydney; Hybrid; AUD 140,000 - 190,000; Full time

Benefits offered by this job

Parental leave up to 18 weeks

Volunteer leave 4 days

Wellbeing Day

Employee Assistance Program

Life insurance

Job summary

Johnson & Johnson in Australia seeks an Assistant Manager, Regulatory Affairs ANZ to lead regulatory activities across Australia and New Zealand, ensure products meet market legislation, and direct post‑marketing lifecycle management.

You will mentor a team of regulatory professionals, sit on ANZ Leadership Teams, and engage with regulators and industry bodies to influence policy. Domestic and international travel is expected (≈10%).

Qualifications

• Bachelor's degree in a scientific discipline (Master's preferred).
• 6–8 years' regulatory experience, ideally in medical devices.
• Strong knowledge of regional regulations and regulatory strategy.
• Excellent organizational and negotiation skills; able to influence senior leaders.
• Willingness to travel domestically and internationally (~10%).

Responsibilities

• Direct growth, innovation and post-marketing Lifecycle Management activities, including claims, renewals, labeling and copy clearance
• Lead regulatory strategies and submissions to health authorities, ensuring ongoing post-market compliance
• Partner with regulators and trade associations to resolve issues and influence policy in line with business strategy
• Anticipate emerging risks and drive best-practice regulatory policies, processes and SOPs
• Develop the team, influence as a key leadership team member and manage the department budget

Skills

Regulatory knowledge

Strategic thinking

Communication skills

Leadership ability

Travel willingness

Education

Bachelor's degree in a scientific discipline

Master's degree (preferred)

Job description

Johnson & Johnson in Australia seeks an Assistant Manager, Regulatory Affairs ANZ to lead regulatory activities across Australia and New Zealand, ensure products meet market legislation, and direct post‑marketing lifecycle management.

You will mentor a team of regulatory professionals, sit on ANZ Leadership Teams, and engage with regulators and industry bodies to influence policy. Domestic and international travel is expected (≈10%).