Medical Device Regulations - Mentorship and Support

We’re looking for a Medical Device Regulations - Mentorship and Support who can  volunteer in a hybrid role both remotely (online) and in-country for a total of 6 months. 

• This assignment seeks to support in the enhancement and implementation of a robust regulatory framework for medical devices, aligning with international best practices and tailored to Bhutan's unique needs and regulatory landscape. 
• To be considered for this role, you’ll need a minimum bachelor's degree qualification in a relevant field such as biomedical engineering or pharmacy with a specific focus on medical device regulation or regulatory affairs
• As a volunteer, you will support in identifying key areas where the Medical Product Division requires support and build local capacity, focusing on developing a comprehensive understanding of medical device regulations.

About the Partner Organisation 

The Medical Product Division, under the Bhutan Food and Drug Authority (BFDA), was formerly known as the Drug Regulatory Authority. Following the civil service reform process in Bhutan, the Drug Regulatory Authority merged with the Food and Narcotics Control Authorities to form the BFDA. The agency's vision is to achieve excellence in protecting and advancing the health and safety of the nation. The mission of Medical Product Division is to safeguard the health of humans and animals by ensuring the quality, safety, and effectiveness of medical products.  The Medical Product Division (MPD) is still in the early stages of regulating medical devices and faces significant challenges due to a lack of specialised technical expertise. Currently, the division faces challenges due to insufficient in-depth knowledge of medical device technologies which are necessary for evaluating complex technical dossiers and conducting thorough assessments. Another critical issue is an inadequate skills for Market Surveillance and limited capacity to monitor and manage adverse event reporting; conduct post-market inspections and investigate safety concerns. In this context, the engagement of an Australian volunteer with expertise in medical device regulation could play a pivotal role. Such support would enable the Medical Product Division to build capacity, strengthen both pre- and post-market regulatory systems, and ensure alignment with international best practices. This collaboration would be invaluable in establishing a robust regulatory system capable of addressing the unique challenges associated with medical device regulation in Bhutan.

About the Australian Volunteers Program  

The Australian Volunteers Program is an Australian government-funded initiative. We support partner organisations across the Pacific, Asia, and Africa to achieve locally led change.  

Volunteers are supported throughout their volunteer journey. We actively support and encourage people of all backgrounds and abilities to volunteer and aim to make the program as accessible and inclusive as possible. If you have accessibility requirements, please contact us to discuss how we can support you to volunteer with us - inclusion@australianvolunteers.com. Learn more about our commitment to inclusion.