Technical Officer, Medical Devices
Vor 2 Tagen
DESCRIPTION OF DUTIES
Under the general supervision of the PQT Unit Head, the Technical officer shall:
Generic duties
Participate in the development of innovative technical health policies and strategies for implementation through collaboration with Regional and Country Offices and in developing further the prequalification of priority medical devices (MDs) and personal protective equipment (PPE) for strengthening and improving technical capacity of target clienteles. Participate in the development and monitoring work plans and budgets for the team's activities and implementation of planned activities. Participate in the analysis of data and information on best practices in implementing sustainable public health programmes and dissemination of information. Participate in research activities and the implementation of the subunit's activities and dissemination of information for capacity building in the respective area of work. Assist in monitoring and evaluation of the specific field of work and conducting timely reporting for decision makers. Upon delegation represent WHO at various meetings. Perform all other related duties as assigned.Specific duties(Two or three Specific duties could be added if required for the specific assignment in a specific region)
Participate in the establishment and implementation of the process for prequalification of priority medical devices (including software as medical device and personal protective equipment (PPE). Participate in the development of technical evaluation specifications and protocols for the independent performance evaluation of products (MDs and PPE). Participate in the assessment of priority medical devices (MDs) and personal protective equipment (PPE):with 3rd part laboratories (, FIND for the pre-screening of CAD for TB software) in the performance evaluation of priority MDs and PPE.
with experts in the evaluation of products (MDs and PPE).
c.Participate in the preparation of final assessment reports detailing the expert panel evaluations of the product applications against the technical specifications.
d.Participate in the preparation of communication with applicants on the outcomes of assessment.
e.Participate in implementation and monitoring of the QMS performance of the process for PQ of priority MDs and PPE.
REQUIRED QUALIFICATIONS
Education
Essential :
First level university degree (Bachelor's) in Biomedical Engineering, Materials Science and Engineering or related sciences from a recognized University.Desirable :
Certificate in clinical or biomedical engineering. Knowledge of Quality Management Systems ISO13485 or any other quality assurance systems for medical devices or PPE.
Experience
Essential :
At least five years of relevant experience in any one or a combination of the following:
Business /procurement experience within the Medical Device Industry, regulatory and quality experience. Assessing medical device technology, preferably Health technology regulation or management Regulation of a relatively broad range of medical devices (MDs) or personal protective equipment (PPE) in relevant Industry in production, quality control or quality assurance of medical devices (MDs) or personal protective equipment (PPE).Desirable :
Exposure to WHO-PQT procedures and working with regulatory authorities in low- and middle-income countries (LMIC) will be and added advantage. Experience in procurement or quality assurance of medical devices, preferably hospital medical devices.
Skills
A sound general knowledge of medical devices evaluation and registration, preferably with in-depth knowledge of design, development, safe use and monitoring performance of medical devices. An in-depth knowledge of international regulatory requirements for marketing authorization (registration) of medical devices (MDs) and personal protective equipment (PPE).
WHO Competencies
Teamwork Respecting and promoting individual and cultural differences Communication Producing results
Use of Language Skills
Essential :
Expert knowledge of English.Desirable :
Beginners knowledge of French.-
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