Médecins Sans Frontières (MSF) is an international, independent, medical humanitarian organization created in 1971 that delivers emergency aid to people affected by armed conflict, epidemics, healthcare exclusion and natural disasters.
The MSF Foundation is a satellite entity created by Médecins Sans Frontières (MSF) dedicated to medical innovation for the humanitarian context.
The MSF Foundation encourages a collaborative approach, developing specific networks and seeking external expertise (universities, start-ups and research centres) to share with MSF.
Its mission, on behalf of MSF, is to be a laboratory of innovation and to incubate projects with high uncertainty and impact for the humanitarian sector.
As part of a fixed-term position (12 months), we are looking for a:
Quality assurance and regulatory affairs specialist M/W
POSITION BACKGROUND
In the past 4 years, The MSF Foundation has been working on the development of a mobile device application that supports laboratory technicians with the reading and interpretation of antibiograms in low- and middle-income countries.
The MSF Foundation aims to deploy this application called Antibiogo free of charge in all countries with limited resources to support the fight against antimicrobial resistance by ensuring a reliable diagnosis of bacterial infections. The application is currently in the performance evaluation phase.
The MSF Foundation intends for mid-2022 to CE certify Antibiogo under the In Vitro Diagnostic European Directive. The objective for this year is to deploy Antibiogo routinely in the 5 MSF laboratories (Jordan, Mali, Yemen, Liberia, CAR) and in 2023 to extend it within the different MSF intervention countries and explore models for making the tool available beyond MSF.
PLACE IN THE ORGANISATION
The RA/QA specialist will report to the RA/QA manager.
OBJECTIVES OF THE POSITION
The RA/QA specialist is responsible for the activities that lead to and maintain regulatory approval for IVDs developed and made available by The MSF Foundation under EU regulation. The main purpose of this position is to create the quality management system compliant with ISO 13485 and compile the technical documentation for the certification of Antibiogo under the supervision of the RA/QA manager.
MAIN RESPONSIBILITIES
● Participate in product development and sustaining IT engineering teams to ensure appropriate regulatory requirements are incorporated as part of the development and design change process.
● Provides input on and reviews protocols and reports for: design verification, design validation, pre-clinical studies, and clinical studies.
● Author submissions and other regulatory documents to obtain approval to bring new or modified product versions to market.
● Support the development team in regulatory assessment of proposed changes or product transfers; review and approve document action requests.
● Interface and coordinate with Notified Bodies, Conformity Assessment Bodies and Competent Authorities and other regulatory agencies on submissions, approvals or other issues.
● Establish and maintain regulatory information systems.
● Interpret existing and/or new regulatory requirements as they relate to the foundation products and procedures. Communicate this to appropriate personnel.
● Conduct labeling, marketing, product transfer and literature review pre and post market for compliance to: standards, guidelines, regulations, and regulatory approvals/clearances.
● Assist with the development, implementation and maintenance of regulatory SOP’s.
● Manages the creation and review of SOP required to fulfill ISO 13485 requirements.
● Guide The MSF Foundation teams in the writing of the documentation related to the processes they are responsible for.
● Produce all regulatory and quality documentation as needed.
● Responsible for the maintenance of the QMS.
● Provide necessary training to the MSF Foundation employees in accordance with ISO 13485 requirements.
● Be the focal point to external regulatory consultants.
PROFILE REQUIREMENTS
Qualifications
Pharmacist with a master in medical devices registration and regulation.
Other scientific diploma could be considered, if compensated by strong experience in quality assurance of medical devices (regulatory aspects included).
Work experience
Minimum 2 years of experience in regulatory, development or quality assurance in IVD or medical devices. Mandatory.
Regulatory Affairs experience is preferred is an asset.
Experience with regulatory submissions including EU MDR / IVDR Technical File creation and maintenance is desired.
Experience in diagnostics development and/or stand-alone software is an asset.
Experience in determining requirements and options for regulatory approval pathways and compliance activities throughout the product life cycle is a plus.
Knowledge of developing countries and emerging markets is a plus.
Strong interest to work in NGO environment.
Languages: Fluent written and spoken French and English essential (B2).
Specific Requirements: Strong organizational skills and attention to detail required ; Ability to work in a fast-paced/entrepreneurial environment ; Ability to work in a cross-functional, highly interdependent team structure ; Results and goal oriented ; High degree of initiative with the ability to work independently ; Ability to clearly convey or exchange information with internal and external stakeholders ; Willingness to seek out diverse ideas, opinions, and insights and apply them in the workplace ; Excellent time management skills.**
Status: Fixed Term contract – 12 months – Full Time – Some travel is expected abroad.
Conditions: 44 946 € gross per year based on 13 months. 22 days RTT per year. Health insurance covered 100% by Médecins Sans Frontières. Restaurant vouchers of 9€ (covered 60% by Médecins Sans Frontières). Reimbursement of 50% of the public transport ticket.
Expected starting date: April 2022.
How to apply
Please submit your application (CV and cover letter) online at:
Deadline for application is 03/03/2022
Please note that only selected candidates will be contacted.