Regulatory Affairs Manager

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 Lead regulatory strategy and enable market access across ANZ. At BD, possibility isn’t an idea. It’s what we do. We are the Makers of Possible. We’re seeking an experienced Regulatory Affairs Manager to join BD on a 12‑month maternity leave contract, providing strategic regulatory leadership across Medical, Connected Care and Interventional portfolios in Australia and New Zealand. In this role, you’ll lead the Regulatory Affairs team, guide high‑impact submissions, and partner closely with the business to ensure products are registered, maintained and imported in line with regulatory requirements. You’ll play a critical role in enabling BD’s commercial objectives while upholding the highest regulatory and ethical standards. This opportunity is ideal for a seasoned regulatory leader who enjoys balancing strategy, people leadership and hands‑on regulatory execution. Your Day‑to‑Day As Regulatory Affairs Manager, you’ll provide direction, oversight and leadership across a broad and complex regulatory landscape. Your day will include: Providing strategic regulatory direction and monitoring the progress of submissions across ANZ Leading and developing the Regulatory Affairs team, ensuring performance and capability align with current and future business needs Partnering with local Business and Functional leaders to align regulatory strategy with commercial and corporate goals Managing regulatory activities to ensure compliance with TGA, Medsafe, and other relevant regulatory bodies (including DAFF and NZ MAF) Overseeing the preparation and submission of general marketing applications to the TGA and Medsafe Maintaining strong, professional relationships with key regulatory authorities and industry bodies Supporting the business with regulatory input into promotional plans and representative training activities Ensuring promotional materials are compliant with regulatory requirements and the Medical Technology Industry Code of Practice Providing ANZ regulatory expertise to regional and global stakeholders Contributing to regional and international regulatory networks and initiatives Undertaking project work and special assignments as required About You You’re a confident, credible regulatory leader with deep technical expertise and a collaborative mindset. You’re comfortable operating at a strategic level while staying close to execution when required. You’ll bring: Bachelor’s degree in Regulatory Affairs, Quality, Science or a related discipline (Master’s in Regulatory preferred) Extensive experience in Regulatory Affairs within the medical device industry Strong experience operating in Australia and New Zealand regulatory environments Proven people leadership experience (this role has 2 direct reports) Experience in managing regulatory submissions and product lifecycle maintenance Strong stakeholder engagement and influencing skills Experience with international medical device licensing (preferred) Excellent problem‑solving, decision‑making and root cause analysis capability Ability to work confidently across local, regional and global teams 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 talent and supporting career progression. Here in ANZ, a large % of our roles are filled internally - we don’t just promise development, we deliver it. You’ll join a collaborative, high‑performing team where regulatory excellence is recognised as a critical enabler of patient outcomes and business success. Because at BD, possibility isn’t just imagined - it’s made. What’s in It for You 12‑month maternity leave contract in a leadership role Broad regulatory scope across multiple medical technology segments Opportunity to lead and influence ANZ regulatory strategy High visibility with local, regional and global stakeholders Supportive team environment and strong cross‑functional partnerships Meaningful work enabling access to life‑changing medical technologies Ready to Make the Move? If you’re an experienced Regulatory Affairs leader ready to step into a high‑impact maternity cover role - 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.