Regulatory Affaires Manager

Была больше месяца назад

По договорённости

46 лет (родилась 21 ноября 1979), не состоит в браке, детей нет

Москва

Занятость

полная занятость

Гражданство

не указано

Контакты

Телефон

Почта

Будут доступны после открытия

Фото, имя и контакты доступны только авторизованным пользователям

Опыт работы 22 года и 10 месяцев

- Июнь 2011 – работает сейчас
- 14 лет и 6 месяцев
Regulatory Affairs Manager Russia and CIS / registration of the medical devices
Covidien Eurasia, Москва
Обязанности и достижения:
1. Manage the work of Regulatory Affairs Specialists 2. Ensure that all medical devices commercialized by Covidien in Russia and CIS countries meet all commercial and regulatory requirements; 3. Ensure that all information received from post market surveillance activities e.g. complaints, are entered into the relevant business units systems for processing; 4. 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; 5. Provide relevant certificates and declarations of conformity of the commercialized medical devices as requested; 6. Liaise with manufacturing facilities, if required, to obtain technical information that may be required to support commercial or regulatory requirements; 7. Archiving and follow-up of quality complaints, incidents or adverse events from customers and respective reporting to the concerned departments of Covidien and to the health authorities, if required; 8. Verify approval of all medical devices for sale in Russia and the CIS markets, in JBA Item master system; 9. Verify promotional and advertising material regarding commercialized medical devices; 10. Coordinate product holds and perform effective recalls, if directed by Covidien RA/QA; 11. Inform EMEA Regulatory Affairs of any legal modifications in local regulations which may affect the distribution activities of Covidien; 12. Provide assistance to other departments, as requested, to assist in projects and other relevant activities. 13. Actively represent Covidien in front of the governmental agencies and bodies in the Russia and CIS 14. Actively cooperate with distributors in Russia and CIS 15. Manage work of Regulatory Consultancies in Russia; Ukraine and other countries 16. Represent Covidien in the local trade associations i.e. IMEDA 17. Provide assistance to other departments, as requested, to assist in projects and other relevant activities.
- Декабрь 2007 – июнь 2011
- 3 года и 7 месяцев
Regulatory Affaires Manager (Russia and CIS countries)
PRA International (Global CRO), Москва
Обязанности и достижения:
Perform all aspects of the Clinical Start-Up and Regulatory Activities at the country level to achieve successful activation of the sites in accordance with ICH GCP, applicable regulations and requirement. • Supervises clinical operations staff dedicated to country start-up activities on a projects • Participates in design and development of Patient Informed Consent Templates with applicable regulations, requirement and others study specific documents as required • Liaises with Regulatory Affaires Associate assigned to the project to ensure MoH submission is performed as applicable • Ability to step into the Clinical team Manger Position on a temporary basis when required • Assist Clinical team managers in developing study tools/documents/processes/tracking tools • Conduct document review as needed (for the submissions and site’s activation processes) • Participates in the project team meetings as required • Participates in the Investigational Product Release Process (liaise with Reg Affaires Associates in order to be sure the import license submission is done accurate in accordance with regulations and requirements) • Deliver appropriate study specific trainings to clinical operations staff to country start –up activities • Maintain knowledge of ICH GCP, applicable regulations and requirements per country, SOPs • Contributes to positive team dynamics through active effective listening and communication including interactive participation in team meetings, sharing of information and proactive problem identification/solving
- Апрель 2006 – декабрь 2007
- 1 год и 9 месяцев
Ассистент специалиста по организации клинических исследований
Clinical Trial Research Company, Москва
- Сентябрь 2002 – октябрь 2005
- 3 года и 2 месяца
Преподавтель
Волгорадский Государственный Университет, Волгоград
Обязанности и достижения:
Создание ряда методических пособий для студентов и написание научных статей

Образование

- Высшее образование
- Дневная/Очная
- 2002
Волгорадский Государственный Университет
Факультет: Филологический
Специальность: Переводчик в сфере профессиональных коммуникаций
- Высшее образование
- Дневная/Очная
- 2002
Волгоградский государственный университет
Факультет: Истории и международных отношений
Специальность: Регионовед

Обо мне

Дополнительные сведения:

Ответственность, коммуникабельность, аккуратность, способность работать в стрессовых ситуациях, находить правильные решения. Компьютерные навыки: Excel, word, Kodak Imagine, etc.