Regulatory Approval Officer

Вакансия № 21872793 в населенном пункте (городе) Москва, Россия от компании "OMRON Healthcare Europe" 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 № 21872793 добавлена в базу данных: Воскресенье, 7 сентября 2025 года.

Дата обновления этого объявления: Суббота, 27 сентября 2025 года.

Рейтинг вакансии: 11,95 из 100 баллов

Вакансия № 21872793 прочитана - 170 раз(а)
Отправлено откликов - 0 раз(а)

Вакансии Электронного ЦЗН Москвы в соцсетях и мессенджерах:

Работодатель предложит заработную плату по результатам собеседования с соискателем работы.

OMRON Healthcare Europe is looking for a Regulatory Approval Officer to join our strong European Quality Assurance & Regulatory Affairs department. We offer you the opportunity to be part of our important mission to help realize healthier and comfortable lives for people around the world.

We are looking for an independent proactive individual who is detail orientated, structured, thorough and a strong communicator. This person needs to speak both Russian and English.

The Regulatory Approval Officer based in Moscow, Russia is responsible for medical device registration in Russia and in Commonwealth of Independent States (CIS). You will manage and control the regulatory approval/market access process so that product launch schedules are met, customer satisfaction is achieved including compliance with the applicable regulatory requirements, within the scope of OMRON Healthcare Europe-Group’s (OHE) quality management systems and policy and in accordance with business direction. The role implies the proactive communication with relevant departments of OHE, OMRON Healthcare Headquarters in Japan (OHQ) and Business Partner related to regulatory approval processes.

Your Key Activities:

Manage the process of product registration & Market Access Approval in the designated countries proactively to allow “as early as possible” product registration including:
- providing all required documents and certificates
- managing all steps of regulatory approval process up to the market launch
- maintaining registration during the product lifetime until discontinuation
Developing registration guidelines per country and other relevant cross-functional SOP’s, creating, and maintaining registration databases.
Assist with analysis and make recommendations regarding complaints received and whether they are reportable within the designated areas; participate in post-market surveillance activities as necessary.
Manage necessary contacts with local authorities and organizations for regulatory problem solving, obtaining update information on current and developing regulations, product list clarification and launch timelines alignment.
Remain current on developing regulations and communicate to broader organization and provide training as necessary and assist with the development of the Russia & CIS Regulatory Affairs infrastructure and processes to facilitate greater speed to market.
Participate in and/or support various teams and projects to ensure compliance to regulatory requirements for the designated sales areas, identify relevant guidance documents and standards, and assist teams with their interpretation and assist with determination of regulatory pathways for various projects including product classification and type of regulatory submission required.
Manage changes to existing products initiated by different parties like OHQ, OHE and BP's including impact-analysis, executing consequent actions, and aligning the process between relevant departments within OHE-G and OHQ and BP's.

Desired Skills and Experience

The ideal candidate would have:

At least 2 years of experience as Registration Specialist in Russia, medical devices class risk 2a or higher
Basic product knowledge of BPMS or Nebulisers is preferred
In depth knowledge of business processes / procedures
In depth knowledge of the regulatory frameworks and requirements in Russia and CIS countries for Medical Devices
Basic knowledge of Quality Management system ISO 13485
Basic knowledge of the Medical Device Directive EEC 93/42 and Medical Device Regulation 2017/745 and medical device related international standards
Proficient in the English and Russian language, both written and verbal
Good knowledge of Microsoft Office (Word, Excel, Adobe, SharePoint)
Focused and attention to detail, strong influencing skills, able to make it happen
Able to set priorities and structured approach in their work

OMRON Core Competencies