Technical Officer, Medical Devices

OBJECTIVES OF THE PROGRAMME

The Department of Regulation and Prequalification Department (RPQ) works with Member States and partners to improve the access to essential medicines and other health technologies of assured quality, safety and efficacy or effectiveness. The RPQ department works with the Access to Medicines and Health Products Division (MHP) division departments in the wider framework of Universal Health Coverage and category 4 of the Global programme of Work and cooperates with disease-oriented programmes (among others HIV/AIDS, TB, malaria, reproductive health, maternal and child health, immunization, NCDs and mental health) towards the Sustainable Development Goals. The department works with a wide range of UN organizations, international partners and expert networks, and WHO Collaborating Centres. The prequalification of priority MDs and PPE is a standardized assessment procedure of WHO to evaluate the acceptability of MDs and PPE to be purchased by WHO Member States, UN procurement agencies and other NGOs or donors so that they are assured of their quality, safety, performance and suitability for use in LMIC. The aim of the WHO prequalification of priority MDs and PPEs program is to promote and facilitate access to safe, appropriate products of good quality. The PQ program aims to develop a systematic approach to assess technical specifications, regulatory aspects and certifications, quality management system, accessories and consumables, packaging, legal and environmental requirement, installation and commissioning, product safety and post-market surveillance of existing and new products (MDs and PPEs). The program will also help to prequalify MDs and PPEs for other emergency situations and priority diseases.

DESCRIPTION OF DUTIES

Under the general supervision of the PQT Unit Head, the Technical officer shall:

Generic duties

1. 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.
2. Participate in the development and monitoring work plans and budgets for the team’s activities and implementation of planned activities.
3. Participate in the analysis of data and information on best practices in implementing sustainable public health programmes and dissemination of information.
4. 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.
5. Assist in monitoring and evaluation of the specific field of work and conducting timely reporting for decision makers.
6. Upon delegation represent WHO at various meetings.
7. 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)

1. 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).
2. Participate in the development of technical evaluation specifications and protocols for the independent performance evaluation of products (MDs and PPE).
3. Participate in the assessment of priority medical devices (MDs) and personal protective equipment (PPE):

a.Liaise with 3rd part laboratories (e.g., FIND for the pre-screening of CAD for TB software) in the performance evaluation of priority MDs and PPE.

b.Liaise 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.

REMUNERATION

WHO salaries for staff in the Professional category are calculated in US dollars. The remuneration for the above position comprises an annual base salary starting at USD 64,121 (subject to mandatory deductions for pension contributions and health insurance, as applicable), a variable post adjustment, which reflects the cost of living in a particular duty station, and currently amounts to USD 4729 per month for the duty station indicated above. Other benefits include 30 days of annual leave, allowances for dependent family members, home leave, and an education grant for dependent children.

ADDITIONAL INFORMATION

• This vacancy notice may be used to fill other similar positions at the same grade level
• Only candidates under serious consideration will be contacted.
• A written test and/or an asynchronous video assessment may be used as a form of screening.
• In the event that your candidature is retained for an 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.
• According to article 101, paragraph 3, of the Charter of the United Nations, the paramount consideration in the employment of the staff is the necessity of securing the highest standards of efficiency, competence, and integrity. Due regard will be paid to the importance of recruiting the staff on as wide a geographical basis as possible.
• Any appointment/extension of appointment is subject to WHO Staff Regulations, Staff Rules and Manual.
• Staff members in other duty stations are encouraged to apply.
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• Persons with disabilities can request reasonable accommodations to enable participation in the recruitment process. Requests for reasonable accommodation should be sent through an email to reasonableaccommodation@who.int
• An impeccable record for integrity and professional ethical standards is essential. WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
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