Regulatory & Quality Business Partner at BD Canada

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

06 Oct, 26

Salary

0.0

Posted On

08 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Quality Assurance, Medical Device Regulations, TGA Compliance, Medsafe Compliance, ISO 13485, Product Lifecycle Management, Stakeholder Management, Risk Mitigation, CAPA, Post-market Surveillance, QMS Management

Industry

Medical Equipment Manufacturing

Description

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description 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. At BD, possibility isn’t an idea. It’s what we do. We are the Makers of Possible. 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. Your Day‑to‑Day You will operate as the key RA/QA partner to the business, balancing compliance with commercial priorities. You will: 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 You’ll play a central role in ensuring the business can grow while maintaining strong compliance standards. About You You’re a confident business partner who can translate regulatory requirements into practical, workable solutions. You’ll bring: 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. Why BD? BD is one of the world’s largest medical technology companies, but we’ve never lost our human touch. With over 70,000 associates worldwide, we’re committed to developing careers. Here in ANZ, a large percentage of roles are filled internally - we don’t just promise growth, we deliver it. Because at BD, possibility isn’t just imagined - it’s made. What’s In It for You Newly created role with ownership of a newly integrated portfolio Exposure to both pre‑market and post‑market regulatory activities Opportunity to shape how a new business integrates into BD Involvement in future digital, software and AI‑driven product evolution Work across ANZ with strong global connectivity A collaborative, high‑impact business partnering role This role offers the opportunity to work on a new and evolving portfolio, with exposure across ANZ and global teams, and the chance to contribute to future innovation in software and AI‑enabled healthcare solutions. Ready to Make Your Mark? If you’re ready to step into a role where you can influence regulatory and quality outcomes while supporting business growth — apply today and join BD as a Maker of Possible. Why Join Us? To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers. 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. Required Skills Optional Skills . Primary Work Location AUS Sydney - North Ryde Additional Locations Work Shift 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. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. 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. Join our company and see how you can become a part of one global mission to make a difference in human health.

Responsibilities

Act as the primary RA/QA partner for a newly integrated product portfolio across Australia and New Zealand. Ensure regulatory compliance throughout the product lifecycle, from pre-market registrations with TGA and Medsafe to post-market surveillance and quality management.