Technical Advisor – Health Technology Products, Kathmandu 119 views

Technical Advisor – Health Technology Products

Overall Background

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.

Tags

biomedical engineering

essential medicines

global health

health systems

health technology

human resources

information systems

management information systems

medical devices

pharmacy

trainings

transparency

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 MINIMUM EDUCATION

Required:

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

Required:

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.

Preferred:

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

COMPETENCIES

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.

PHYSICAL DEMANDS

Ability to travel in-country to support technical activities.

Keyboard use, pulling drawers, lifting papers <10 lbs., etc. MSH is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, sex, sexual orientation, gender or gender identity, religion, creed, citizenship, national origin, age, veteran status, or disability unrelated to job requirements. MSH will take affirmative action to ensure that qualified applicants are employed and that employees are treated without regard to their race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran and disability status. In compliance with U.S. Department of Labor Executive Order 11246, Section 503 of the Rehabilitation Act, and Section 4212 of the Vietnam Era Readjustment Assistance Act, MSH has developed and maintains an affirmative action program and plan. EEO is the Law - English EEO is the Law - Spanish EEO is the Law Supplement Pay Transparency Nondiscrimination Poster MSH EEO-AA Policy Management Sciences for Health (MSH) is a global health nonprofit that makes foundational changes to health systems to protect people from diseases and improve their health. MSH collaborates with local partners, from the Ministry to the community, to strengthen and complement existing health systems. Since 1971, MSH has worked in more than 150 countries to help ensure sustainable, resilient, and equitable access to quality health care around the globe. If you are a candidate in need of assistance, an accommodation, or an alternative method to apply for an open position, please email talentacquisition@msh.org or call +1-703-524-6575 to be connected with Human Resources. ckbERk5-B5DZg0

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