The goal of the global five-year USAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program is to help low- and middle-income countries to strengthen their pharmaceutical systems to ensure sustainable access to and appropriate use of safe, effective, quality-assured, and affordable essential medicines and pharmaceutical services. MTaPS, implemented by Management Sciences for Health (MSH) and partners, will provide technical assistance to the Ministry of Health and Population (MOHP) and the Department of Drug Administration (DDA) including other relevant implementing agencies to strengthen pharmaceutical systems including pharmaceutical sector governance, good pharmacy practices, regulatory systems, pharmaceutical management information systems, and improve patient-centered pharmaceutical services.
The Directorate of Drug Administration, Nepal is regulating drugs as per the provision of Drug Act since 1979 however regulation of medical devices has not been started. Few years back the medical devices directive was issued but it is still to be implemented.
The Technical Advisor – Health Technology Products (TA-HTP) will under the leadership of Principal Technical Advisor (PTA) – Inspection provide management support and technical assistance for the design and implementation of country strategies for strengthening regulation of medical devices and other health technologies including the process for granting marketing authorization in line with the WHO regulatory framework and guidance.
Key Performance Areas
Technical Support (50%)
- Develop a phased strategy for strengthening regulation of Health Technology Products including Medical Devices in Nepal
- Develop in close collaboration with the DDA a detailed implementation plan for strengthening regulation of MD including registration in Nepal
- Develop legal and administrative measures required to implement the existing Directive on Health Technology Product and Equipment, 2017
- Identify and prioritise the items to be regulated by the Department of Drug Administration authority
- Evaluate and assess the standard specifications of health technology product including the medical devices submitted by the registration holder and on the basis of national and international existing standards for both physical, chemical, toxicological and microbial/sterility testing as appropriate.
- Prepare the quality testing references and manual for HTP including medical devices based on the national and international standards
- Develop registration/listing guideline detailing requirements for the registration of HTP including medical devices
- Develop standard operating procedures (SOP) for management and documentation of HTP and medical devises registration
- Implement Pharmadex registration module for medical devices products registration
- Develop terms of reference for the establishment of a HTP and MD registration committee and support regular meetings
Capacity Building (30%)
- Orientation, advocation and training of HTP/Medical devices importers and manufacturers in product registration and requirements.
- Build DDA capacity in HTP and MD regulation and registration
- Create awareness of HTP and MD registration requirements
Coordination and management (20%)
- Report regularly to the PTA and Country Program Director (CPD) on progress/results achieved in technical work plans and barriers encountered, and resolve any challenges faced.
- Participate in various working groups as required, including making technical presentations on key activities and achievements of assigned areas as needed.
- Maintain close liaison and coordination with senior officials in the MOHP, National Medicines Laboratory and DDA and other key stakeholders e.g., WHO, USAID implementing partners, to ensure technical assistance activities are carried out with their active participation for building ownership.
- Work closely with other MTaPS team members to ensure technical work plans are being implemented in a timely and technically sound manner, and productively leverage collaboration with key government and other stakeholders and partners.
Required Qualification & Experience
Master’s in biomedical engineering or degree related with health technological products or master’s in pharmacy with experience in the health technological products and public health
REQUIRED MINIMUM EXPERIENCE:
- At least five years of relevant experience in regulation of health technological products with a focus on medical devices registration, import/export control, vigilance of the health technology product or equipment
- Considerable experience in the development of standard technical specifications, manuals for medical devices, quality testing references, assessment of technical files prior to listing and performance of quality audits for medical devices manufacturers.
- Experience in the development of training materials and, organizing and implementing training events
- Experience and knowledge of the registration of medical products as well as work experience with a national regulatory authority
KNOWLEDGE AND SKILLS
- Knowledge of pharmaceutical legal and regulatory systems of Nepal.
- Experience in development of manuals for health technology products including medical devices materials
- Experience in developing guidelines and SOPs for classification and listing medical devices
- Strong networking, collaboration, and advocacy skills
- Strong analytical and research skills
- Ability to write and prepare reports, training materials, documents, and presentations
- Excellent written and verbal communication skills in English and Nepali
- Demonstrated intermediate skills in Microsoft Office Suite applications, including Word, Excel, and PowerPoint.
- Strong organizational skills with the ability to handle multiple tasks simultaneously and organize meetings and trainings
- Ability to work independently and effectively in a team.
- Good decision-making skills
- Strong interpersonal and communication skills; ability in consensus building and constructively leading a team.
- Ability to travel in-country to support technical activities.
- Keyboard use, pulling drawers, lifting papers <10 lbs., etc.
How to Apply
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