Regulatory Affairs Lead, ANZ - MedTech & Innovation

Johnson & Johnson Co.; Ryde; Vor Ort; AUD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Up to 18 weeks parental leave

Volunteer leave 4 days

Additional annual leave purchase up to

Wellbeing Day

Global Wellness Reimbursement

Employee Assistance Program

Enhanced caregiver leave up to 30 days

Life insurance

Rights to work in Australia

Zusammenfassung

Johnson & Johnson, a global leader in MedTech and Innovative Medicine, seeks an Assistant Manager, Regulatory Affairs ANZ to drive regulatory activities across Australia and New Zealand. You will mentor a team of professionals, influence policy with regulators and trade associations, and ensure ongoing market compliance while aligning with business strategy.

You will collaborate across the ANZ region, manage post-market life-cycle activities, and contribute to the leadership team while

Qualifikationen

• Bachelor's degree in a scientific discipline (Master's preferred) with 6–8 years' related experience, ideally in medical devices.
• Expert knowledge and practical application of regional government regulations.
• Sound regulatory and business strategy expertise to gain and maintain the legal marketing status of a product portfolio.
• Excellent organisational, communication and negotiation skills, with the ability to influence senior leaders, affiliates, regulators and industry.
• Willingness to travel domestically and internationally (approx. 10%)

Aufgaben

• Direct growth, innovation and post-marketing Lifecycle Management activities, including claims, renewals, labelling 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

Kenntnisse

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

Ausbildung

Bachelor's degree in a scientific discipline

Master's degree preferred

Jobbeschreibung

Johnson & Johnson, a global leader in MedTech and Innovative Medicine, seeks an Assistant Manager, Regulatory Affairs ANZ to drive regulatory activities across Australia and New Zealand. You will mentor a team of professionals, influence policy with regulators and trade associations, and ensure ongoing market compliance while aligning with business strategy.

You will collaborate across the ANZ region, manage post-market life-cycle activities, and contribute to the leadership team while