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About the Role
Shape regulatory and quality outcomes for a newly integrated portfolio across ANZ. Join a global leader in medical technology and play a key role in ensuring compliance while enabling business growth across Australia and New Zealand. As a Regulatory & Quality Business Partner, you’ll step into a newly created role supporting the integration and ongoing management of a newly acquired product portfolio within BD’s ANZ business. You’ll partner closely with commercial leaders, clinical teams and global stakeholders to ensure regulatory and quality requirements are embedded across the full product lifecycle - from pre‑market activities through to post‑market compliance. This is a unique opportunity to work across both strategy and execution, supporting the introduction of new technologies while helping shape how the portfolio evolves within BD - including future alignment with digital, software and AI‑enabled solutions.
Responsibilities
- Operate as the key RA/QA partner to the business, balancing compliance with commercial priorities.
- Partner with commercial and functional leaders to provide practical regulatory and quality guidance.
- Support product commercialisation, ensuring compliance is built into business decisions.
- Manage regulatory submissions, product registrations and lifecycle maintenance with TGA, Medsafe and other authorities.
- Provide RA/QA input into product launches, tenders and customer communications.
- Support integration of the new portfolio into BD systems, processes and governance frameworks.
- Identify and mitigate regulatory and quality risks aligned to business priorities.
- Support post‑market activities including complaints, adverse events, field actions and recalls.
- Ensure adherence to the ANZ Quality Management System (QMS).
- Lead or support audits and drive CAPA closure.
- Monitor regulatory changes and translate them into actionable guidance.
- Partner with regional and global RA/QA teams to ensure alignment.
Requirements
- Experience in Regulatory Affairs, Quality Assurance or combined RA/QA roles.
- Strong understanding of medical device regulations in Australia and New Zealand.
- Experience across product lifecycle activities (pre‑ and post‑market).
- Confidence influencing and partnering with commercial stakeholders.
- Ability to balance compliance requirements with business priorities.
- Strong analytical skills and attention to detail.
- Experience working within a Quality Management System (e.g. ISO 13485).
- Strong communication skills across both technical and non‑technical audiences.
- Ability to operate in a matrixed regional/global environment.
- A background in MedTech or regulated healthcare environments is essential.
Skills
- Regulatory Affairs
- Quality Assurance
- Medical device regulations
- Product lifecycle management
- TGA
- Medsafe
- Quality Management System (QMS)
- ISO 13485
- CAPA
- Digital
- Software
- AI
Location
- Sydney - North Ryde, Australia
Work Type
- Full-time
Experience Level
- Mid-level
Benefits
- Opportunity to work on a new and evolving portfolio.
- Exposure across ANZ and global teams.
- Chance to contribute to future innovation in software and AI-enabled healthcare solutions.
- Culture where face-to-face collaboration supports learning, progress, and success.
About the Company
- BD is one of the largest global medical technology companies in the world.
- Advancing the world of health™ is our Purpose.
- BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum.
- With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all.
Equal Opportunity
- Becton, Dickinson, and Company is an Equal Opportunity Employer.
- We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.