Job Description Lead regulatory strategy and enable market access across ANZ. 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. 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 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 stakeholdersSupportive 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 . 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, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Primary Work Location: AUS Sydney - North Ryde Additional Locations: N/A Work Shift: N/A #J-18808-Ljbffr
Regulatory Affairs Manager
BD
council of the city of sydney, council of the city of sydney
Published 4 days ago
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