National Consultant for the regulation on medical devices registration and guidelines


Location : Vientiane Capital, LAO PDR
Application Deadline :14-Aug-22 (Midnight New York, USA)
Time left :2d 16h 31m
Additional Category :Management
Type of Contract :Individual Contract
Post Level :National Consultant
Languages Required :
English  
Starting Date :
(date when the selected candidate is expected to start)
22-Aug-2022
Duration of Initial Contract :51 working days
Expected Duration of Assignment :August 2022 - August 2023


UNDP is committed to achieving workforce diversity in terms of gender, nationality and culture. Individuals from minority groups, indigenous groups and persons with disabilities are equally encouraged to apply. All applications will be treated with the strictest confidence.

UNDP does not tolerate sexual exploitation and abuse, any kind of harassment, including sexual harassment, and discrimination. All selected candidates will, therefore, undergo rigorous reference and background checks.


Background

As Lao PDR faced serious shortages and price fluctuations of medical supplies during the pandemic of COVID-19 as the country is fully dependent on imports. The pandemic also highlighted the critical need for quality control of these products in the market. This project will develop the capacity of a state-owned factory for the first large-scale domestic production of Personal Protective Equipment (PPE) through material and technical support. The project also aims at establishing a quality management system through the development of standards and guidelines, as well as capacity development activities. 

Lao PDR faced serious shortages and price fluctuations of medical supplies during the pandemic of COVID-19, as the country is wholly dependent on imports. The critical need for supply and quality control of the medical products in the market has appeared as one of the challenges for sustainable socio-economic development in Laos. To adapt to this situation, the Government of Lao PDR has the ambition to capture this opportunity to promote the high-quality local production capacity of PPE and improve the quality assurance of the items available in the market. 

In addition, the quality of imported and domestically produced medical devices and supplies in the market vary significantly due to the limited regulation and surveillance capacity. The government acknowledges the critical need to enhance its regulatory capacity by developing a PPE Manufacture Establishment Guidelines, National Medical Device Registration Regulations, and PPE Inspection Guidelines and tools. 

To tackle the adverse impacts of the pandemic, UNDP Lao PDR has supported the Government of Lao PDR with a comprehensive portfolio to respond to COVID-19 directly. In this context, in close cooperation with the Ministry of Health, UNDP Lao PDR initiated this project by providing financial and technical support to enhance the domestic production of Personal Protective Equipment (PPE) and a quality management system for PPE production and better market access. 

OBJECTIVE:

The project’s objective is to strengthen the COVID-19 preparedness, response and recovery capacities at the Asia-Pacific regional level, focusing on four countries (Bangladesh, Maldives, Lao PDR and Pakistan) with the aim to minimize and address the regression on SDG attainment and to enhance these countries’ socio-economic development.  The objective of this project is to enhance local PPE production and supply capacity in Lao PDR and to ensure the quality of PPE for COVID-19 and other future pandemics. 

In this context, UNDP Lao PDR is seeking an experienced consultant with legal background to support Food and Drug Department, Ministry of Health of Lao PDR (FDD) to develop the guidelines under the national the medical devices regulation.  

 


Duties and Responsibilities

SCOPE OR WORK:

The successful applicant will be expected to be responsible for the following:

  • Provide support to FDD to review and develop the national guideline and ensure the documentation in Lao and English are appropriate.
  • Assist FDD and the international consultant to organize and facilitate workshops for drafting, developing, and finalizing the National Guidelines for Lao PDR.
  • Provide support to FDD and the international consultant to plan and conduct capacity development training.
  • Assist FDD for translation, legal research, and report writing in Lao and English languages


Competencies

  • Good facilitation and coordination skills
  • Result oriented, patient, and hands-on with good teamwork skills
  • Good computer skills (word, excel, power-point, internet, and other related matters)
  • Capacity development techniques


Required Skills and Experience

Educational qualifications

  • A Bachelor’s degree in law. A Master’s degree is preferred 

Experience and Skills

  • At least 2 years of experience working in the field of legal affairs
  • Advanced knowledge in laws and regulations in Lao PDR is required 
  • Knowledge and experience in medicine, pharmacy, toxicology, or related field is a significant advantage. 
  • Previous work experience in translation is a plus 
  • Previous work experience in conducting or facilitating workshops and capacity development training is a plus 

Language requirements

• Excellent verbal and written skills in English and Lao is required. Expertise in Thai is a significant advantage

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HOW TO APPLY

 

Requirements for submission of proposals 

All interested and qualified International Consultant should apply on-line using the following links: 

UNDP Lao PDR Country Office website at https://www.undp.org/laopdr/jobs  or  

In order to make your submission, please read the relevant documents available on the link below 

  1. TOR
  2. IC General Terms and  Conditions Annex II

  3. Offerors Letter to UNDP Annex III

  4. P11 Form

  5. IC - Contract Template

Interested Individual Consultants must submit the following documents/information to demonstrate their qualifications: 

  1. Technical Proposal (Free-Form):
  • Explaining why you are the most suitable for the work; 
  • Providing a brief methodology on how you will approach and conduct the work, including the work schedule for the delivery of outputs/deliverables; 
  • P11 Form: Education and work experience, including past experience in similar projects and contact references of at least three references for whom you have rendered preferably the similar services; 

       2. Financial Form (OFFEROR's LETTER): Lump sum offer with clear cost breakdown against each deliverable.

Instructions for Online Submissions: 

  • Step 1:  Please prepare all required documents electronically; 
  • Step 2: Combine all the required documents in ONE SINGLE FILE (preferably in PDF; however, Word format can also be accepted) and upload to the UNDP Jobs website using the link above; 
  • Step 3: After that, you will receive an auto-reply from the UNDP Jobs website if your offer is received successfully. 

Incomplete Proposals or Proposals received after the deadline will be rejected. 

Note:  Any request for clarification must be sent in writing before the submission deadline to the following email: surith.sengsavang@undp.org



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