Medical Device UniQuality & Unidata Product Information Specialist

Job Posting Organization:
Médecins Sans Frontières (MSF) is an international, independent, medical humanitarian organization founded in 197

• MSF delivers emergency aid to people affected by armed conflict, epidemics, healthcare exclusion, and natural disasters. The organization operates in over 70 countries and has 24 sections, 28 associations, and 19 branch offices. MSF is registered in Switzerland and provides coordination, information, and support to the MSF Movement, implementing international projects and initiatives as requested. MSF is committed to an inclusive culture that encourages and supports the diverse voices of its employees, welcoming applications from individuals of all backgrounds.

Job Overview:
The Medical Device UniQuality & Unidata Product Information Specialist position is focused on ensuring that information related to medical devices is complete, accurate, and available for relevant MSF stakeholders. The role involves managing product information, ensuring compliance with quality assurance processes, and acting as the primary point of contact for stakeholders regarding product information. The specialist will contribute to MSF's social mission by ensuring the availability of trusted, standardized, and high-quality product information, which supports field operations, supply chain performance, and interoperability through centralized data stewardship and collaboration with diverse stakeholders. This position is integral to the ongoing improvement of MSF's medical device management and quality assurance processes.

Duties and Responsibilities:

• Management of Entities in UniQuality: Create, validate, and update medical device entities according to relevant SOPs. Approve entities for international purchase by checking data completeness in public databases.
• Management of ISO Certificates: Ensure that information related to ISO certificates is updated and consistent. Request updated documentation from relevant stakeholders.
• MD Repository Management: Ensure compliance with rules for uploading and tagging documentation. Assist end-users with practical use of the MD Repository.
• Eudamed Monitoring: Follow up on the use of Eudamed modules and train different groups in its practical use.
• General Improvements: Propose updates to SOPs and action plans for data quality improvement. Implement annual reports on data quality.
• Product Information Management: Monitor and process requests for product changes, ensuring product availability and suitability for field use.
• Harmonization and Interoperability: Collaborate with various teams to standardize products across MSF operations.
• Data Stewardship: Maintain high-quality product information and ensure compliance with regulatory standards.
• Data Ownership: Ensure accessibility and visibility of product information. 1
• Process Design: Design and enhance processes related to data requirements and product information governance. 1
• Collaboration: Work closely with MSF field staff and stakeholders to ensure product standardization and quality.

Required Qualifications:
A Master’s degree in scientific, engineering, pharmacy, or paramedical sciences is required. Candidates must be detail-oriented, organized, and possess strong computer and analytical skills, including proficiency in MS Excel. Knowledge of the medical devices regulatory environment (MDR/IVDR) and ISO standards is a plus. Candidates should have excellent communication skills, be customer-oriented, resilient, and self-motivated with a strong interest in problem-solving. Technical writing skills are also essential.

Educational Background:
Candidates must hold a Master’s degree in a relevant field such as scientific, engineering, pharmacy, or paramedical sciences. This educational background is crucial for understanding the complexities of medical devices and their regulatory requirements.

Experience:
Candidates should have experience in MSF field or supply roles in a medical position, which is considered an asset. Experience in managing product information and quality assurance processes is highly desirable. The role requires a fast learner who can adapt quickly to a changing environment and manage multiple tasks effectively.

Languages:
Proficiency in English (both speaking and writing) is mandatory, and knowledge of French is also required. Additional language skills may be beneficial but are not specified as mandatory.

Additional Notes:
This is a permanent contract position at 100% capacity, with a starting date of December 1, 202

• The position will remain open until a suitable candidate is selected. The successful candidate will be offered a contract in the MSF office that can issue a contract in their country of residence at the time of application. If no MSF office exists in their country, relocation may be necessary. MSF is committed to preventing abuse and misconduct in its work environment and expects all staff to uphold these values.