E-DRUG: Call for consultant: WHO Regulatory Convergence and Networks Team (RCN) - deadline 15 August 2021
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WHO is seeking an experienced consultant to help our Team in Geneva to provide technical support to revise and update the WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices (GMRF). The duration of consultancy is up to 6 months.
Under the overall supervision of the Team Lead of Regulatory Convergence and Networks the Consultant will carry out the following tasks:
- Propose and process changes in the development of a revised and updated version of the GMRF;
- Develop guidance texts with the collaboration and input from experts in the field of medical devices;
- Engage with a core working group, consisting of WHO/HQ staff members, that will guide the revision the process of revision and update;
- Discuss with a working group of relevant regulatory experts and staff from WHO/HQ and WHO Regional Offices the drafted texts per topic and per chapter to obtain feedback, input and support from regulatory authorities and targeted audience;
- Initiate regular virtual meetings with the working group of regulatory experts;
- Consult international harmonizing organizations such as IMDRF, GHWP, AMDF, ISO, IEC;
- Prepare a consultative meeting on the pre-final text of the revised and updated version of the GMRF;
- Prepare a public consultation on the final text of the revised and updated version of the GMRF;
- Develop a proposal for implementation workshops of the revised GMRF;
- Submit final text of the revised and updated GMRF.
The successful candidate will need to demonstrate the following qualifications/expertise/skills:
Qualifications required:
- First university degree in pharmacy, medicine, biology, biochemistry, chemistry, microbiology or related science. Post-graduate degree (Master's level or above) in pharmacy, medicine, biological sciences, or other health science-related field.
Experience required:
- At least 10 years professional experience in regulating medical devices;
- Extensive knowledge on medical devices including In vitro diagnostics and their regulation.
Skills and knowledge:
- 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;
- Good professional drafting and communication skills;
- Advanced computer literacy and knowledge of regulatory IT systems and databases.
Language requirements:
- Expert knowledge of English is essential. Ability to work in other UN languages would be an asset.
Only selected candidates will be contacted (individually) by the WHO Secretariat.
Curriculum vitae should be submitted to WHO/RPQ/REG by electronic mail to azatyans@who.int with the following title: "Call for consultant REG/RCN"
The deadline for applications is 15 August 2021.
Dr Samvel AZATYAN
Team Lead
Regulatory Convergence and Networks [RCN]
Regulation and Safety [REG]
Regulation and Prequalification [RPQ]
World Health Organization
"AZATYAN, Samvel" <azatyans@who.int>