Associate Director - Commercial Quality & Regulatory Affairs (Medical Devices)

Location: North Ryde, New South Wales, Australia. Applicants must have the right to work in Australia.

Company

Johnson & Johnson MedTech develops innovative medical technology and less invasive, personalised treatments.

What you will do

• Develop and execute quality and regulatory strategies supporting business growth and new product market access across ANZ.
• Provide expert leadership on complex regulatory, quality, and compliance matters as the senior escalation point for the ANZ business.
• Partner with cross-functional teams on product lifecycle management, new product introductions, portfolio optimisation, and business continuity.
• Lead engagement with regulatory authorities, industry associations, and external stakeholders, including audits and inspections.
• Drive quality, compliance, inspection readiness, and continuous improvement across the business.
• Lead, coach, and develop the CQ/RA team while influencing business decisions and stakeholder relationships.

Requirements

• Degree or postgraduate qualification in Regulatory Affairs, Engineering, Science, or a related discipline.
• 8–10 years of specialist Regulatory Affairs and Commercial Quality experience in the medical device industry, including 4–5 years in a leadership capacity.
• Strong knowledge of ANZ regulatory requirements and quality standards, with experience in regulatory submissions, change management, risk management, and regulatory authority interactions.
• Experience with CAPA, validations, quality systems, regulatory inspections, and audits.
• Superior communication, negotiation, project management, prioritisation, and time management skills.
• Right to work in Australia required.

Culture & Benefits

• Inclusive, flexible, and accessible working arrangements.
• Continuous training and support, including leadership development programs.
• Up to 18 weeks of parental leave and enhanced compassionate leave provisions.
• Four days of volunteer leave and the option to purchase up to two additional weeks of annual leave.
• Dedicated Wellbeing Day, an annual global wellness reimbursement of $780, and access to an Employee Assistance Program.
• Life insurance coverage and a competitive remuneration package.