Assistant Manager Reg Aff, Vision ANZ

Johnson & Johnson Co.; Sydney; On-site; AUD 120,000 - 170,000; Full time

Benefits offered by this job

Parental leave: up to 18 weeks

Volunteer leave: 4 days

Additional annual leave: up to 2 weeks

Wellbeing Day

Wellbeing reimbursement: $780/year

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, ensuring products meet market legislation and directing post-marketing lifecycle management. You will mentor a team of regulatory professionals, engage with agencies and trade associations, and shape regulatory strategy in line with business goals.

This role offers competitive remuneration, flexible working arrangements, and opportunities to impact patient

Qualifications

• Bachelor's degree in a scientific discipline; Master’s preferred.
• Experience with regulatory requirements for medical devices and life sciences in ANZ region.
• Ability to lead regulatory strategies and negotiate with health authorities.

Responsibilities

• Direct growth, post-marketing lifecycle management, 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.
• Anticipate emerging risks and drive best-practice regulatory policies, processes and SOPs.

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow,and profoundly impact health for humanity.Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: North Ryde, New South Wales, Australia Job Description: About MedTech Fuelled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalised treatments. Visit us at https://www.jnj.com/medtech to see how your unique talents will help patients on their journey to wellness.

The Opportunity As Assistant Manager, Regulatory Affairs ANZ, you'll lead regulatory activities across Australia and New Zealand, ensuring products meet all market legislation and directing post-marketing Lifecycle Management. You'll mentor a team of regulatory professionals, sit on the ANZ Surgical Vision and Vision Care Leadership Teams, and act as a key regulatory expert, engaging agencies and trade associations to influence changing regulations.

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

About You

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%)

Why Choose Us:

• Competitive remuneration package
• Continuous training and support
• Award-winning leadership development programs
• Inclusive, flexible, and accessible working arrangements
• Equal opportunity employer supporting diversity and inclusion

And much more...

Our Benefits:

• Up to 18 weeks of parental leave to support new parents
• 4 days of volunteer leave to give back to the community
• Option to purchase up to 2 weeks of additional annual leave for extra time off
• Enjoy a dedicated Wellbeing Day to prioritise self-care
• Global Wellness Reimbursement of $780 per year for healthy eating, exercise, or mindfulness activities
• Access to an Employee Assistance Program for personal and professional support
• Enhanced leave provisions for compassionate (caregiver) leave, providing up to 30 days of additional support
• Life insurance coverage for added peace of mind

And much more...

All applicants must have rights to work in Australia.

Required Skills: Preferred 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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/. Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.

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