от компании (организации): АНКОР Медицина и фармация в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Регистратура"
с заработной платой: по договоренности
Вакансия № 1837313 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 24 августа 2024 года.
Дата обновления вакансии № 1837313 на сайте Работа в Москве и Московской области (МО, Подмосковье): Суббота, 21 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 1837313 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: Senior Regulatory Affairs Specialist
In large international company open position Senior Regulatory Affairs Specialist (medical equipment, medical device).
Main responsibilities:
- Ensure that all medical devices commercialized by the company in Russia and CIS countries meet all commercial and regulatory requirements;
- Ensure that all information received from post market surveillance activities e.g. complaints, are entered into the relevant business units systems for processing;
- Ensure that all relevant procedures, Corporate, BU or regional (EP) related to regulatory and quality activities are communicated to relevant local staff and respective distributors;
- Provide relevant certificates and declarations of conformity of the commercialized medical devices as requested;
- Liaise with manufacturing facilities, if required, to obtain technical information that may be required to support commercial or regulatory requirements;
- Archiving and follow-up of quality complaints, incidents or adverse events from customers and respective reporting to the concerned departments and to the health authorities, if required;
- Verify approval of all medical devices for sale in Russia and the CIS markets;
- Verify promotional and advertising material regarding commercialized medical devices;
- Coordinate product holds and perform effective recalls, if directed by RA/QA;
- Inform EMEA Regulatory Affairs of any legal modifications in local regulations which may affect the distribution activities;
- Provide assistance to other departments, as requested, to assist in projects and other relevant activities.
- Manage the work of Regulatory Affairs Assistant.
Requirements:
- University degree;
- Good knowledge of medical devices and pharmaceutical legislation;
- English - upper-intermediate;
- Computer literate;
- Experience in a similar position from 3 years;
- Very well organized.
Откликнуться на эту вакансию: Senior Regulatory Affairs Specialist
Предыдущая вакансия:
Вакансия № 1837309 на должность Regulatory Affairs Manager от компании АНКОР Медицина и фармация в городе (населенном пункте) Москва