от компании (организации): OMRON Healthcare Europe в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Медицинское оборудование"
с заработной платой: по договоренности
Вакансия № 21872793 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Среда, 14 августа 2024 года.
Дата обновления вакансии № 21872793 на сайте Работа в Москве и Московской области (МО, Подмосковье): Вторник, 24 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 21872793 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
1–3 года
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Regulatory Approval Officer
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
- Transparent
- Entrepreneurial
- Passionate about customers
- Making it happen
- Total team player
- Thorough
Please submit your CV in English.
Откликнуться на эту вакансию: Regulatory Approval Officer
Предыдущая вакансия:
Вакансия № 21872780 на должность Помощница по хозяйству/Заместитель управляющей загородной недвижимости от компании Шелепина Анастасия Ивановна в городе (населенном пункте) Москва