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Qualifications

Purpose of consultancy

To provide technical guidance to member states and its regional harmonizing initiatives in the development and implementation of regulation on medical devices.

Background

The regulation of medical devices including in-vitro diagnostics is critical in assuring their quality and performance. In May 2014 the World Health Assembly (WHA) adopted a Resolution regarding regulatory systems for medical products (WHA 67.20). The Resolution underscored the importance of effective regulatory systems as an essential component of health system strengthening and contribution to public health. WHO decided to develop guidance to support Member States that have yet to develop and implement regulatory controls relating to medical devices.

Deliverables

• Objective 1. Publication and dissemination of the WHO Global Model Regulatory Framework for medical devices including in vitro diagnostic medical devices (IVDs).
  • Deliverable 1.1: Contribute to the design and finalization of the revised WHO Global Model Regulatory Framework for medical devices including IVDs (GMRF).
  • Deliverable 1.2: Development of a publication and dissemination plan for the GMRF.
• Objective 2. To promote regulatory cooperation, convergence, harmonization, and work-sharing in regulation of medical devices including IVDs through the provision of technical expertise in the development and implementation of harmonized technical requirements and guidelines involving international and regional regulatory networks and initiatives.
  • Deliverable 2.1: Facilitation of meetings with the AMDF Leadership and AMDF Technical Committee.
  • Deliverable 2.2: Advise the AMDF Leadership and the AMDF Technical Committee on key issues with regard to Objective 2.
  • Deliverable 2.3: Development of a Concept-note for Centers of Excellence for market authorization and market surveillance and control.
  • Deliverable 2.4: Development of a strategy for local production of medical devices for the AMDF Technical Committee in collaboration with WHO Local Production Unit.
  • Deliverable 2.5: Development a Concept-note on joint reviews and inspections for the AMDF Technical Committee.
• Objective 3. To contribute to the development of technical guidance.
  • Deliverable 3.1: Development of technical guidelines on registration and listing; EUL, labeling , and FSCA.
  • Deliverable 3.2: Conduct a survey on landscape analysis on manufacturing of medical devices in Africa.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

• Advanced university degree in pharmacy, biology, medical laboratory technology, or any related field.

Experience

Essential:

• Over 10 years of professional experience in regulating medical devices.

Skills/Knowledge:

Essential:

• Extensive knowledge of medical devices including in-vitro diagnostics and their regulation.
• Excellent ability to communicate and work in diverse settings.
• Advanced computer literacy and knowledge of regulatory IT systems and databases.
• Good professional drafting and communication skills.

Languages required:

Essential:

• Expert knowledge of English.

Desirable:

• Intermediate knowledge of French and Spanish.

Location

Off site: Home-based

Travel

The consultant is not expected to travel.

Remuneration:

Band level C-USD 10,000 – 12,500 per month.

Living expenses (A living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract :

11 months

Additional Information :

• This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
• Only candidates under serious consideration will be contacted.
• A written test may be used as a form of screening.
• If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
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