Regulatory Affairs Leader, ANZ — MedTech Innovation

Brighter Signals; Ryde; On-site; AUD 140,000 - 180,000; Full time

Benefits offered by this job

Parental leave

Volunteer leave

Wellbeing Day

Life insurance

Job summary

Johnson & Johnson is seeking an Assistant Manager, Regulatory Affairs ANZ, to lead regulatory activities across Australia and New Zealand, ensuring products meet market legislation and managing post-marketing lifecycle. You will mentor a team of regulatory professionals and engage with regulators and associations to influence policy.

You will work with a senior leadership team to drive regulatory strategy and compliance, travel domestically and internationally as needed, and contribute to

Qualifications

• Bachelor's degree in a scientific discipline required with 6–8 years' related experience, ideally in medical devices.
• Expert knowledge of regional government regulations and post-market lifecycle management.
• Strong business strategy and regulatory leadership capabilities to maintain marketing status of product portfolio.
• Excellent organizational, communication and negotiation skills; able to influence senior leaders.
• Willingness to travel domestically and internationally (approx. 10%).

Responsibilities

• Direct growth, innovation and post-marketing lifecycle management activities, incl. claims, renewals, labeling and copy clearance.
• Lead regulatory strategies and submissions to health authorities, ensuring ongoing post-market compliance.
• Collaborate with regulators and trade associations to influence policy aligning with business goals.
• Identify and mitigate regulatory risks; develop policies, processes and SOPs.
• Develop the team and budget; participate as a key leadership team member.

Skills

Analytical Reasoning

Communication

Collaboration

Problem Solving

Regulatory Affairs Management

Regulatory Compliance

Public Policies

Strategic Thinking

Coaching

Product Licensing

Legal Support

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, ensuring products meet market legislation and managing post-marketing lifecycle. You will mentor a team of regulatory professionals and engage with regulators and associations to influence policy.

You will work with a senior leadership team to drive regulatory strategy and compliance, travel domestically and internationally as needed, and contribute to