Medical Device Regulatory Roadmap for the Dream Warmer

Global Newborn Solutions (GNS) is seeking a Regulatory Affairs Advisor to help us bring the Dream Warmer, a non-electric infant warmer, to the infants who need it most.

The volunteer will focus on 2-3 priority markets (to be selected from Sub-Saharan Africa, South/Southeast Asia, or Latin America) to:

- Map applicable medical device regulatory frameworks in the target countries.
- Identify the specific Dream Warmer classification and conformity assessment requirements for each.
- Produce a detailed registration roadmap including estimated timelines, costs, and necessary documentation.
- Conduct a knowledge-sharing session with the GNS team to discuss findings and implementation.

More details will be provided during the interview.

By creating a practical regulatory pathway for the Dream Warmer™, volunteers will help clear barriers to distribution in resource-limited settings, accelerating access to a device that prevents newborn hypothermia and supports neonatal survival—directly advancing GNS’s mission.

Details will be provided during volunteer interviews. Success will be a clear, actionable multi-country registration roadmap that GNS can use to pursue approvals, plus completed knowledge-sharing sessions that raise internal regulatory awareness and enable next steps.