от компании (организации): Avanta Россия в городе (населённом пункте): Москва, Россия
в отрасли экономики "Производство, сельское хозяйство" → "Сертификация"
с заработной платой: от 135000 до 140000 руб.
Вакансия № 25921736 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Четверг, 15 августа 2024 года.
Дата обновления вакансии № 25921736 на сайте Работа в Москве и Московской области (МО, Подмосковье): Пятница, 20 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 25921736 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: Quality assurance & regulatory affairs specialist (medical devices) - Специалист по регистрации
Our Client is an international company.
Responsibilities:
- Perform registration process for medical devices and work independently on each step from initialization till license obtained – under national Registration Rules and under EAEU legislation procedure
- Ensure effective project management for product registration and re-registration in collaboration with registration consultancy
- Review registration documents and dossier preparation (including filing application forms and test protocols check) with expertise for registration submission directly /with consultancy
- Communicate with foreign manufacturers for request of product dossier for registration
- Coordinate all registration-related activities for project (consultancy, samples ordering, testing remarks correction to HA)
- Compile, coordinate and monitor renewals for medical devices in accordance with the national and EAEU legislation
- Maintain of registered products dossier and registration license up to date, amendments proceeding, change impact assessment
- Support of registration in CIS countries
- Manage of product complaints, timely reporting into local system, data trending.
Required Knowledge and Skills:
- Higher / Professional education
- Strong knowledge of relevant medical device industry regulations
- Experience in conducting a full cycle of registration of medical devices is required (not medicines, not cosmetics)
- Experience in certification according to technical regulations, notification
- Knowledge of the rules of the Customs Union
- English – upper-intermediate
- Ability to accurately work with large amount of data from various sources
- Responsibility
- Attentiveness to details
- Time-management and problem-solving skills
- Ability to work effectively within a team in a fast-paced changing environment
- Ability to effectively communicate in English in verbal and written
- Result-focus
Conditions:
- Work in a professional team
- International environment
- Professional development and career growth
- Fixed salary + annual bonus
- Voluntary medical insurance & life insurance
- Mobile phone.
Откликнуться на эту вакансию: Quality assurance & regulatory affairs specialist (medical devices) - Специалист по регистрации
Предыдущая вакансия:
Вакансия № 25921733 на должность Врач-оториноларинголог от компании ГБУЗ МО Мытищинская городская клиническая больница в городе (населенном пункте) Королев