от компании (организации): ООО Терумо Рус в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Сертификация"
с заработной платой: по договоренности
Вакансия № 13557119 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 24 августа 2024 года.
Дата обновления вакансии № 13557119 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 22 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 13557119 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
3–6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: The Regulatory Affairs (RA) Specialist
The Regulatory Affairs (RA) Specialist will be responsible for the preparation of regulatory submissions required to market new or modified medical devices in Russian Federation. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business.
RA Specialist is to take care of services in regulations, registrations, technical files and standards and to assist in the complaint handling for devices related to a business unit.
RESPONSIBILITIES
- Manage new registration and registration dossier update of assigned Terumo products, ensure continued compliance and timely market release in Russia
- Interact with Terumo headquarters, manufacturers, national competent authorities, consulting, translating agencies and other partners involved in product registration
- Control timelines and budget
- Obtain other required permission documents (declarations of conformity, import permits, licenses etc.)
- Assess registered product changes impact, define and implement necessary activities on local level
- Ensure compliance of labeling and instruction for use of the products with the applicable regulations on local level
- Review and approve product related promotional materials for compliance with applicable regulations and policies
- Support local team on regulatory issues
- Monitor medical device legislation in Russia and EurAsian union, define, communicate and maintain an overview of the regulatory requirements and changes in the areas
- Participate in working (focus) groups of national and/or international trade associations as a representative for Terumo
- Support the complaint handling for assigned products
PROFILE REQUIRED
Bachelor's degree / University degree, preferably, in a field of medicine / engineering / quality / law.
Minimum 2 years’ experience in the medical devices industry in the RA department.
Current knowledge of and good practice in the Russian medical device regulations, legislation requirements and standards.
Ability to effectively communicate in English both verbally and in writing to all levels within the organization and external to the organization.
Ability to work with big amount of information.
Ability to work with minimal supervision on projects and activities.
Ability to prioritize, plan & organize work; project management experience desirable.
Excellent knowledge of MS Office.
WORK CONDITIONS
- The level of remuneration will be discussed individually;
- Good career experience in international company;
- Friendly environment;
- Voluntary Medical and Accidental insurance;
- Meal allowance;
- Corporate SIM-card;
- Comfortable office in Moscow Business Center "Moscow City".
Откликнуться на эту вакансию: The Regulatory Affairs (RA) Specialist
Предыдущая вакансия:
Вакансия № 13557115 на должность Главный специалист проектировщик по слаботочным системам, автоматике и диспетчеризации от компании Brazen Group в городе (населенном пункте) Москва