E-DRUG: Call for consultant - WHO Regulatory Networks and Harmonization Group - deadline 26 March 2019
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Call for consultant: Regulatory Networks and Harmonization Group in WHO RHT/RSS Team
Dear colleagues,
WHO is seeking an experienced consultant to help our Team in Geneva to advance the work with our Member States in strengthening regulatory systems for medical products and health technologies - with the focus on the regulation of medical devices (including in-vitro diagnostics). Specifically, the incumbent will be involved in the development and implementation of harmonized technical requirements, promoting convergence and work-sharing and contributing to accelerated access to essential quality assured medical devices (including in-vitro diagnostics) by supporting development and implementation of reliance and collaborative registration processes and other facilitated registration pathways. The work contributes to the strategic goal of the WHO to strengthen regulatory capacity of Member States with respect to medical devices as well as enabling the normative base for regulating medical devices. The duration of consultancy is 6 months.
Under the overall supervision of the Group Lead of the Regulatory Networks and Harmonization the Consultant will carry out the following tasks:
- Provide technical support to Member States and Regional Regulatory Harmonization Initiatives in regulatory matters related to the medical devices (including in-vitro diagnostics) within the scope of the implementation of WHO Global Model Regulatory Framework for medical devices and adopted national work plans or upon requests by the respective Member States or Harmonization Initiatives;
- Promote regulatory cooperation, convergence, harmonization and work-sharing in the area of medical devices (including in-vitro diagnostics) through the provision of technical expertise and assistance in the development and implementation of harmonized technical requirements and guidelines involving international and regional regulatory networks and initiatives;
- Facilitate the development and use of relevant WHO and other internationally recognized guidance and WHO good regulatory practices at the national, regional and international levels;
- Provide assistance in the revision and development of the WHO Global Benchmarking Tool (GBT) to address the specific issues of regulation of medical devices (including in-vitro diagnostics);
- Participate in National Regulatory Authority (NRA) benchmarking in selected countries as well as in the Regional Regulatory Harmonization Initiatives as part of the WHO regulatory systems strengthening programme;
- Contribute to accelerating access to essential quality assured medical devices (including in-vitro diagnostics) by supporting development and implementation of reliance and collaborative registration processes and other facilitated registration pathways, including joint regulatory activities;
- Undertake other tasks as required by the Group Lead of Regulatory Networks and Harmonization Group and Coordinator of RSS Team.
The successful candidate will need to demonstrate the following qualifications/expertise/skills:
- Excellent understanding of the concepts of medical product regulation including for medical devices and of WHO's policies and strategies in this area.
- Good knowledge of product development and production as well as issues related to regulation of and access to medical products, especially in the context of low- and middle-income countries.
- Proven ability to plan and implement new strategies and activities to achieve a goal. Ability to function effectively in and liaise with multi-sectoral stakeholders with high level of tact and diplomacy. Excellent interpersonal, negotiating and communication skills including presentation skills.
- Substantial knowledge of all aspects of project management and development.
Education qualifications required:
A first university degree in biomedical engineering, pharmacy, medicine, biology, biochemistry, chemistry, microbiology or related science. Post-graduate degree (Master's level or above) in biomedical engineering. pharmacy, medicine, biological sciences, or other health science-related field.
Experience:
At least seven years experience in regulation, production and/or development of medical products including medical devices at national and/or international level. Experience is also required with national decision making and in advisory and advocacy roles to senior government officials and policy makers.
Only selected candidates will be contacted (individually) by the WHO Secretariat.
Curriculum vitae should be submitted to WHO/RHT/RSS by electronic mail to azatyans@who.int
with the following title: "Call for consultant RSS/RNH"
The deadline for applications is 26 March 2019.
Dr Samvel AZATYAN
Group Lead
Regulatory Networks and Harmonization [RNH]
Regulatory Systems Strengthening [RSS]
Regulation of Medicines and Other Health Technologies [RHT]
Access to Medicines, Vaccines and Pharmaceuticals [MVP]
World Health Organization
Geneva, Switzerland
"AZATYAN, Samvel" <azatyans@who.int>