Assistant Manager Regulatory Affairs, Vision ANZ

About the role

Johnson & Johnson's MedTech division is hiring an Assistant Manager, Regulatory Affairs ANZ, based in North Ryde, New South Wales. The role leads regulatory activities across Australia and New Zealand, ensures products meet market legislation and directs post-marketing Lifecycle Management. It also involves mentoring a team of regulatory professionals, sitting on the ANZ Surgical Vision and Vision Care Leadership Teams and acting as a key regulatory expert who engages agencies and trade associations to influence changing regulations.

Key responsibilities

• 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, act as a key leadership team member and manage the department budget

Required profile

• Bachelor's degree in a scientific discipline (Master's preferred) with 6-8 years of related experience, ideally in medical devices
• Expert knowledge and practical application of regional government regulations
• Ability to influence senior leaders, affiliates, regulators and industry
• Willingness to travel domestically and internationally (approximately 10%); applicants must have rights to work in Australia

Required skills

• Regulatory affairs management, regulatory compliance and regulatory reporting
• Regulatory development and risk assessments
• Product licensing and public policy
• Business writing, strategic thinking and negotiation

What we offer

• Competitive remuneration package
• Up to 18 weeks of parental leave, 4 days of volunteer leave and enhanced compassionate leave (up to 30 days)
• Wellbeing day and global wellness reimbursement of $780 per year
• Employee assistance program and life insurance coverage
• Continuous training, leadership development programs and flexible working arrangements