Head of Regulatory Affairs
About BON CHARGE™
BON CHARGE is Australia’s fastest-growing wellness brand, offering the widest range of premium, science-backed products under one roof. Founded in 2017, BON CHARGE is a pioneering technology company dedicated to simplifying wellness by delivering innovative solutions that enhance sleep, recovery, beauty, and overall wellbeing.
Named by LuxLife as Best Holistic Wellness Brand 2025 in Australia, BON CHARGE is committed to delivering premium experiences. Its mission is to simplify wellness, by offering the world’s best science-backed technology together on one platform.
Our values are fulfilled by supporting more than 250,000+ athletes, doctors and other customers worldwide, who have chosen to drive tangible, positive changes in their lives.
With a bold vision for continued global growth, BON CHARGE is building a world-class team based in our state-of-the-art Sydney CBD office.
About the role
We are seeking a dynamic and visionary Head of Regulatory Affairs to lead our global regulatory capabilities. This pivotal role will oversee the entire regulatory lifecycle for our innovative portfolio that encompass medical devices, wellness products, beauty technologies, and consumer goods. You will be responsible for developing and executing robust regulatory strategies that accelerate product launches, secure rapid market access, whilst ensuring compliance, and manage ongoing life cycle management across markets, including the US, Canada, EU, UK, Australia, Asia, and the Middle East.
We are looking for a candidate who combines comprehensive regulatory knowledge with exceptional technical leadership. Your ability to navigate intricate and changing regulatory environments with speed and precision will be critical. You will be a key driver of business growth by ensuring our products reach markets efficiently and compliantly. This is an ideal opportunity for a results-oriented professional who flourishes in a fast-paced setting and is passionate about contributing to business growth.
The successful candidate will demonstrate a compelling blend of IQ and EQ. Superior verbal and written communication skills are crucial, especially the being able to translate complex technical and regulatory information into clear, actionable insights for business partners. A proactive, problem-solving approach and a strong orientation towards finding effective solutions are key attributes.
At BON CHARGE, we are ambitious, fast-paced, and committed to excellence. We set high standards for ourselves and each other, creating an environment where talented individuals can achieve incredible career growth and development. You’ll be part of a team that’s driven to be in the top 1% of what we do — if you’re looking for a place where you’ll be challenged, supported, and constantly learning, we’d love to hear from you.
Key Responsibilities
- Develop and lead the execution of a global regulatory strategy that aligns with business priorities, product roadmap, and market expansion goals.
- Provide authoritative regulatory guidance across the full portfolio, including medical, wellness, and beauty devices, as well as consumer goods, ensuring requirements are met from product development through to post-market.
- Continuously monitor global regulatory and competitive landscapes to identify emerging risks and opportunities. Proactively assess the potential business impact of regulatory and commercial trends and implement strategies to mitigate risk and maintain competitive advantage.
- Ensure sustained compliance with applicable global regulatory frameworks, including but not limited to:
- Medical Devices: EU MDR, 21 CFR Part 820 (FDA), Health Canada MDEL, UK MDR, Australian Therapeutic Goods (Medical Devices) Regulations
- Consumer Goods/Electronics: REACH, RoHS, FCC, IEC, California Prop 65, and applicable ISO standards (e.g., ISO 13485, ISO 9001)
- Lead regulatory lifecycle management, including oversight of post-market surveillance, vigilance and incident reporting, license renewals, and regulatory maintenance activities.
- Collaborate cross-functionally with Quality, R&D, Clinical, Commercial, Legal, and Operations teams to ensure early and ongoing regulatory input across all phases—from concept through commercialization and routine operations.
- Design, implement, and continuously improve regulatory systems and tools within the company’s Quality Management System (QMS) to support scalability, compliance, and audit readiness.
Key Requirements
- Bachelor’s degree in a relevant engineering, scientific, or health-related discipline; a relevant postgraduate qualification is highly desirable but not essential.
- Proven experience in global regulatory affairs, with hands-on responsibility across multiple jurisdictions, including the USA, EU, UK, Canada, and Australia; experience in additional regions (e.g., Asia, Middle East, Latin America) is highly valued.
- In-depth knowledge of relevant regulations, standards, and frameworks, such as ISO 13485, MDSAP, FDA 21 CFR Part 820, and other applicable regulatory systems.
- Demonstrated ability to develop practical, solutions-oriented approaches to regulatory challenges.
- Exceptional analytical, communication, and interpersonal skills, with the ability to engage confidently with internal and external stakeholders.
- Proven ability to work cross-functionally and influence without direct authority, building strong collaborative relationships across disciplines.
- Track record of creative problem-solving, especially in navigating complex or ambiguous regulatory scenarios.
- Strong project management skills, with the ability to prioritize, execute, and deliver results under pressure.
- Meticulous attention to detail, combined with strong organizational and planning capabilities.
- Comfortable in fast-paced, dynamic environments, adept at managing multiple priorities and deadlines simultaneously.
- Experience in leading teams and cross-functional projects, including working with external partners, contractors, or consultants.
Why Join BON CHARGE?
- Be part of a global wellness brand at a pivotal growth stage.
- Build the content function from the ground up alongside an award-winning creative team.
- Work alongside passionate founders and a supportive executive team that truly champions creativity and innovation.
- Help shape the brand voice for a business that’s redefining health, wellbeing, and modern wellness rituals.
- Competitive salary package and strong career growth potential.
- A workspace that feels like a wellness retreat: our HQ is designed with intention — think diffusers with calming botanicals, daily fresh fruit, a curated tea bar, gourmet coffee, natural light, and ergonomic stand-up desks.
- Join a team that genuinely values culture, fun, and connection — where wellness isn’t just a product we sell, but something we live and breathe every day.