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.

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.

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