Quality and Regulatory Specialist (medical devices, in vitro diagnostics)
Вакансия № 26503049 в населенном пункте (городе) Москва, Россия от компании "Acsour" на сайте Электронный Центр Занятости Населения (ЦЗН) Москвы.
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Обязательное требование к опыту работы искомого сотрудника: 1–3 года.
График работы: полный день.
Тип занятости: полная занятость.
Вакансия № 26503049 добавлена в базу данных: Пятница, 29 августа 2025 года.
Дата обновления этого объявления: Суббота, 27 сентября 2025 года.
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Работодатель предложит заработную плату по результатам собеседования с соискателем работы.
The leading global provider of in vitro diagnostics is looking for Quality and Regulatory Specialist Russia.
Please provide CV in English only.
The role:
Ensure compliance of Company products marketed in CIS countries with current local regulations:
- To support all regulatory, registration and external affairs activities in the region collecting and providing documents required for local approval and/or tenders, including on request activities (i.e. filing in applications, local forms)
- To provide regulatory support for sales, marketing activities and the distributors requests
- To monitor implementation of new regulatory / legal requirements in the relevant countries, maintaining Regulatory submission and change tracker support and escalate to the EMEA QRC lead
- Assistance to the EMEA QRC lead in defining regulatory strategies in support of local business operations
- Regulatory interface with distributors and local competent authority
2. Deliver Regional Registration Milestones in Russia and CIS countries per plan and populate submission tracker
- To support all regulatory, registration and external affairs activities in the CIS region collecting and providing documents required for local registration processes
- To support new registrations in Russia including:
- To collect and coordinate with global Regulatory and R&D collection of technical documentation pack for registration processes in Russia; to write extraction from manufacturer technical file according to local requirements; to perform editor correction of Russian IFUs according to local requirements of State Authorities
- To plan, organize and support local technical and clinical testing for registration processes in Russia, organization importation of medical devices with the aim of its testing
- To collect, handle and calculate all the results received in technical and clinical testing of medical devices to be registered in Russia; to write and edit reports on technical and clinical testing of medical devices to be registered in Russia
- To collect all the documents of registration dossier to be submitted for registration in Russia; to support requests from State Authorities during registration process in Russia
- To populate submission tracker in the company including information about new registrations
- To provide insert change procedure for existing registrations including document collection, organization of technical and clinical testing, dossier submission and answers to requests of State Authorities
3. Supporting Russia/CIS Quality Management System set-up and rolling out in alignment with the Regional and Global Quality System: Product Quality Management (FSCA, Re-call, producers communications, vigilance), Suppliers/Distributors Quality Management (Quality Agreement, Change Control, non-conformances, internal/external audit and inspection programs), general QMS support (training plans, QSMR, Procedures). Participation in other Quality initiatives announced by Global and/or Regional QRC Management
What you will be doing:
CIS countries registration/declaration, tender support: Collecting Products/Production Documents, filling the local forms and drafting explanation letters in timely manner
Support new registrations and insert change procedures in Russia including documents collection and editing, organization of clinical and technical testing, registration dossier collection; support requests from State Authorities during registration process in Russia
Tracking regulatory requests (IRRT, follow-ups, escalation, archive maintenance), distributors and business team status update
Regulatory watch: Local regulation monitoring, Regulatory change tracker support, escalation. Input to NPI and product change notification
Support Russia/CIS Product Quality Management (FSCA, Re-call, producers’ communications, tenders)
Support CIS Suppliers/Distributors Quality Management (Quality Agreement, Change Control, non-conformance, internal/external audit and inspection programs)
Support CIS QMS general activities (training plans, QSMR, Procedures)
Participation in other Quality initiatives announced by Global and/or Regional QRC Management
Participate to key local trade associations
Performing other work-related duties as assigned
The individual:
More than 2 years experience in a quality or/and regulatory role in the medical device and/or IVD industry.
University degree in medicine, PhD (the last is preferable)
Overall experience 3+ years in a highly regulated environment pharma/medical
English language - Intermediate Level
Microsoft Office skills knowledge and capabilities
Competencies: will be an advantage knowledge of national Russia/CIS registration procedures, IVDD/IVDR requirements, ISO9001 awareness
Analytical skills, versatility, agility, goal-oriented
Required travel - 10-15% (local and international)
The role is based in Moscow, Skolkovo office, hybrid-model.
Thank you for you CV in English!
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