Regulatory Affairs Manager
In-Office, Macquarie Park, New South Wales
- 求人ID
- R-542432
- Category
- Regulatory Affairs
- Location
- Macquarie Park, オーストラリア
- Region
- APAC
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 experiencedRegulatory Affairs Managerto join BD on a12‑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 contractin 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 todayand join BD as aMaker 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 visithttps://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.
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