Lead consultant to provide business analysis services for development of the state medical devices register | ПРООН

UNDP is seeking the services of a qualified professional to provide business analysis services for the development of the state medical devices register. The main objective of this assignment is to conduct business analysis for processes connected with the State medical devices register (SRMD) in part of medical device certification process, device registration process, and social reimbursement process.

Nowadays, there is no unified register of medical devices in Ukraine; A register of medical equipment of manufacturers is maintained instead. The lack of a single register of medical devices leads to the impossibility of harmonizing the legislative field with the European Union. The procedure for adding information on medical devices does not allow the integration of such data into other software products, including those used to implement the electronic inventory management system of medicines and medical devices “eStock”, because there are no unified requirements for the amount and quality of information to be provided.

Hence, the ultimate goal of this assignment is to create the grounds for the development of a national State medical devices register (SRMD) system, a single information space for data exchange and interoperability between all participants in the process related to medical devices at all stages of their life cycle – from applying for registration to market control. The implementation of this task involves the development of a single unified approach to adding information about each medical device, the use of common interfaces, reference books, and standards of work. The system should be implemented as a centralized register of medical devices with a central database and integration with all medical information systems.

The Consultant will be responsible for conducting the following activities in order to achieve the overall goal of the assignment:

• Conducting interviews with stakeholders in frames of their current functions, further functional requests and potential user experience;
• Review and analyse national and international legislation which regulates end-to-end processes for the system;
• Work with stakeholders to define business processes, stakeholder needs and their flow;
• Describe and analyse “as is” business process;
• Suggest and describe “to be” business process for the Register target model;
• Compilate requirements, description of back-end logic;
• Provide recommendations for the legal changes of the Register’s and related processes regulation;
• Estimation of projects cost using appropriate systems, tools, and techniques;
• Planning and prioritizing projects backlog and development for the systems;
• Compilate technical requirements for the development of the Register as procurement documentation;
• Support preparation of procurement procedures (if necessary).

Required experience and qualifications:

• At least a university degree (Bachelor’s) IT, business analysis, management or other related field or relevant certificates;
• At least 2 years of experience in IT as a business analyst and/or system analyst;
• Knowledge of document analysis, writing user stories, functional decomposition, creating and using BPMN and standard UML tools (draw.io, Microsoft Visio or their analogues);
• Proficiency with project management tools: Jira, Confluence, Trello (or analogue) will be an asset;
• The knowledge of API tools (Postman, Altova XMLSpy or their analogues) with logging/monitoring tools (Kibana and Grafana or their analogues) will be considered an asset;
• Proficiency in Ukrainian, working knowledge of English will be an asset.

Documents to be included when submitting the proposal:

1. Personal CV, including information about experience in similar projects / assignments, as well as the email and telephone contacts of at least three (3) professional references;
2. Financial proposal in line with information presented in Section 4. Measurable outputs of the work assignment/deliverables;
3. At least one example of written technical requirements, specifications of ToRs or parts of such documents if there is confidential information that cannot be shared fully. Documents have to be relevant to projects mentioned in the CV;
4. Duly accomplished Letter of Confirmation of Interest and Availability (template may be found at https://cutt.ly/Bzs6D4A).

The application deadline is 9 November 2022.

For more information on the scope of work, requirements, and application process, please visit.