The WHO Prequalification Unit is expanding its scope and is establishing a roster of consultants to support the Prequalification Assessment of Medical Devices.
Consultant for Medical Device Prequalification Assessment
(Home-based consultancy | Global experts welcome)
Starting in 2026, WHO will implement a new procedure for the prequalification assessment of medical devices, complementing its long-standing work on in vitro diagnostics. To support this expansion, WHO is seeking highly experienced medical device experts to review manufacturers’ technical documentation and change requests for prequalified products.
Key areas in the pilot phase include:
• Computer-aided detection (CAD) software for tuberculosis screening
• Contraceptive devices (male & female condoms, copper-bearing IUDs)
• Male circumcision devices
• Medical device software and Artificial Intelligence (AI)
Key responsibilities:
- Technical review of product dossiers for medical devices
- Review of software and AI components
- Assessment of change requests for prequalified products (Reviews are typically conducted within a 4-week timeframe)
Profile sought:
- Advanced university degree in science, engineering, or a related biomedical field (PhD desirable)
- 10+ years of experience in medical device regulatory affairs, QA, development and/or manufacturing
- Strong knowledge of FDA, EU MDR, ISO standards, and global regulatory frameworks
- Demonstrated experience in dossier review and lifecycle management
- Expertise in software/AI medical devices and experience in resource-limited settings are strong assets
Contract details:
- Home-based, remote work (travel may be required)
- Daily rate: USD 350–500 (depending on assignment)
- Contract duration: up to 11 months, with a pre-agreed number of working days
This vacancy will be used to establish a consultant roster to support current and future WHO prequalification activities. Inclusion in the roster does not guarantee immediate assignment but offers the opportunity to contribute to global public health impact.
Applications from women and nationals of non- and under-represented Member States are strongly encouraged.
If you are passionate about medical device regulation and want to support access to safe, high-quality health technologies worldwide, this is an excellent opportunity.
Interested candidates can complete their WHO Stellis profile (see instruction in Annex 1) and submit a copy of the WHO stellis profile together with a cover letter with the subject “Call for Experts – Roster of Consultant for WHO Medical Device Prequalification” to diagnostics@who.int.
Please note that the deadline for submission of application is 15 May 2026 at 17H00.
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