Our Story
Hill Valley Regulatory Consulting was formed in 2023 by Principal Consultant Gary Burgess.
Gary saw a need in the medical technology industry for more knowledgeable, practical, pragmatic and fearless regulatory support for businesses as they try to navigate their way through the complex regulatory environment in Australia, and Hill Valley Regulatory Consulting was created to meet this demand.
Gary runs the business from his home office in Canberra (Australia’s capital), where being in close proximity to the offices of the Therapeutic Goods Administration (TGA) can be very advantageous!
And as for the name and logo? Let’s just say we don’t need roads where we are going!
Background & Experience
Gary Burgess
Director and Principal Consultant
Gary earned his Honours Degree in Biomedical Engineering from Flinders University, Adelaide, and after graduating spent several years in R&D roles.
Gary then gained extensive experience in medical technology regulatory affairs when he joined the TGA as a medical device assessor in 2005.
Gary spent 9 years at TGA building his knowledge of the legislation, and leading teams responsible for the pre-market assessment of medical devices. This also included:
- Becoming a ISO13485 trained auditor and attending audits of Australian manufacturers as a technical specialist
- Representing TGA at the International Medical Device Regulators Forum (IMDRF, previosuly GHTF) on various working groups
Gary moved to the industry in 2014, where he held various roles and gained valuable experience:
- Working for the peak industry body the Medical Technology Association of Australia (MTAA), assisting members and representing the interests of the industry more broadly
- Leading the global regulatory function of Sirtex Medical, an Australian manufacturer of active implantable devices for the treatment of liver cancer
- Leading the Asia-Pacific (APAC) and corporate regulatory functions at Cochlear Limited, globally well-known and regarded Australian manufacturer of active implantable devices (and non-implantable accessories) for the treatment of hearing loss
- Assisting a large variety of clients as a regulatory, quality and compliance consultant at a large consulting firm based in Melbourne
Gary has a passion for developing regulatory strategies which provide optimal commercial advantage while also ensuring appropriate regulatory compliance.
Gary actively participates in industry associations to represent the best interests of clients and the medical technology industry more broadly.
This includes representing industry associations at the TGA’s Regulatory and Technical Forum (RegTech), and participating in TGA-led workshops on various regulatory reforms.
Gary values the importance of continual professional development, including seeking opportunities to present on topics of expertise at conferences and tertiary institutions. This has included chairing and presenting educational sessions at the annual ARCS conference.