Manager, Electrophysiology & Neurovascular (EP/NV) Commercial Quality, ANZ (Medical Devices)

Location: North Ryde, New South Wales, Australia. Full-time role; applicants must have the right to work in Australia.

Company

Johnson & Johnson MedTech develops innovative, less invasive and personalised healthcare treatments at the intersection of biology and technology.

What you will do

• Lead Commercial Quality activities for Electrophysiology and Neurovascular businesses across Australia and New Zealand.
• Execute quality strategies and ensure effective Quality Management System compliance, including CAPA, risk management, audits, inspections and remediation.
• Oversee complaint handling, adverse event reporting, vigilance, field actions, recalls and health authority reporting.
• Provide quality oversight for commercial operations, product introductions, hosted distribution, warehouse processes, logistics, loan kits and service providers.
• Manage supplier, distributor and contracted partner quality performance and represent Commercial Quality with authorities and external stakeholders.
• Lead, coach and develop the Commercial Quality team while managing resources, succession planning and departmental budgets.

Requirements

• Bachelor’s degree in Biosciences, Engineering, Life Sciences, Pharmacy, Operations Management, Quality Management or a related discipline.
• At least 10 years of experience in a regulated industry such as medical devices, pharmaceuticals or healthcare.
• Demonstrated Quality and Compliance experience, preferably in the medical device sector, with people leadership and talent development experience.
• Strong expertise in Quality Management Systems, CAPA, risk management, post-market surveillance and audit management.
• Knowledge of ISO 13485, MDSAP, Australian TGA regulations, New Zealand Medsafe requirements and applicable quality standards.
• Must have the right to work in Australia.

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, Global Wellness Reimbursement of $780 per year and access to an Employee Assistance Program.
• Life insurance coverage and a focus on diversity, inclusion and employee wellbeing.