Associate Director - Commercial Quality & Regulatory Affairs, Sydney

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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:

People Leader

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

Drive quality, compliance, and business growth for DePuy Synthes across ANZ by providing strategic and operational leadership in Commercial Quality & Regulatory Affairs. This role is responsible for developing innovative regulatory strategies that accelerate market access for new products, while serving as a trusted advisor and technical expert on regulatory matters. Working closely with internal and external stakeholders, you will ensure ongoing compliance with regulatory requirements, quality management system standards, health authority expectations, and company policies, while fostering a strong culture of quality, compliance, and inspection readiness across the business.

Responsibilities

• Developing and executing quality and regulatory strategies that support business growth, accelerate market access for new products, and ensure compliance across ANZ
• Providing expert leadership and guidance on complex regulatory, quality, and compliance matters, acting as the senior escalation point for the ANZ business
• Partnering with cross-functional teams to support product lifecycle management, new product introductions, portfolio optimisation, business continuity, and strategic business objectives
• Leading engagement with regulatory authorities, industry associations, and external stakeholders to influence regulatory policy, manage audits and inspections, and strengthening market access outcomes
• Driving a culture of quality, compliance, inspection readiness, and continuous improvement, ensuring alignment with regulatory requirements, quality standards, and company policies
• Leading, coaching, and developing a high-performing CQ/RA team while building strong stakeholder relationships and influencing business decisions across the organisation

About You

• Degree and/or post-graduate qualification in Regulatory Affairs, Engineering, Science or related discipline, with minimum 8-10 years specialist Regulatory Affairs & Commercial Quality industry experience within medical devices, and at least 4-5 years in a leadership capacity
• Strong knowledge of ANZ regulatory requirements and quality standards, and demonstrated experience with regulatory submissions, change and risk management processes, and leading regulatory authority interactions
• Strong attention to detail, along with expertise in CAPA, validations, understanding of quality systems, and experience supporting or leading regulatory inspections and audits
• Superior communication and negotiation skills, with the ability to build trusted relationships with regulators, partners, and internal stakeholders
• Commercial acumen, who is results and solutions focused, along with excellent project management, prioritisation and time management skills
• Ability to work well under pressure to meet deadlines and to make sound decisions daily concerning quality and regulatory affairs

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

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.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. 

 

 

Required Skills:

 

 

Preferred Skills: