от компании (организации): Анселл РУС в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Медицинский представитель"
с заработной платой: по договоренности
Вакансия № 407985 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Среда, 25 сентября 2024 года.
Дата обновления вакансии № 407985 на сайте Работа в Москве и Московской области (МО, Подмосковье): Четверг, 14 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 407985 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: Sr. Specialist, Regulatory
GENERAL SUMMARY OF POSITION:
With direct line reporting to the Regulatory Affairs Manager Russia/CIS and dotted line to the designated Regional RA Director, the Senior Regulatory Specialist Russia/CIS, ensures the implementation of the regulatory and certification requirements for Medical Devices in Russia and CIS. Additionally, the Senior Regulatory Associate ensures compliance to Medical Device Importation Requirements in Russia.
RESPONSIBILITIES & SPECIFIC ACCOUNTABILITIES
- Responsible for all Medical Device Registrations in Russia and CIS. Involving compilation and maintenance of Medical Device Registration dossiers to ensure timely commercialization.
- Responsible for interactions with Russian Certification Centre’s, Testing Laboratories, Regulatory Authorities, Customs, Distributors and Consultants utilized.
- Responsible for ensuring compliance to Russian Medical Device Importation requirements to ensure customs clearance.
- Liaise with local testing laboratories as required to ensure all Medical Devices are in continual compliance with importation and registration requirements.
- Organization of plant audits as required by Regulatory Authorities and attendance at plant audits.
- Provides Regulatory Assessment and Advice for Medical Devices in Russia and CIS.
- Keeping up to date with national & international legislation, guidelines and customer practices in Russia and CIS in relation to Ansell Medical Devices.
- Understanding and evaluating complex information; resolving registration or importation problems if they arise.
- Play an active role in the EMEA and Global Regulatory Affairs teams.
- Provide assistance as required in dossier compilation and registration in the EMEA APAC region.
- Other duties as requested
Education
- University Degree preferably in a relevant field of study ie medicinal, pharmaceutical, chemical or engineering.
Job Experience
- Responsibility for Medical Device Dossier Compilation in Russia and preferably of other countries within the CIS.
- Responsibility for liaison with Regulatory Authorities.
Knowledge and Skills
- Written and spoken English
- Knowledge of Medical Device Regulations and Medical Device dossier requirements in Russia and CIS.
- Ability to liaise with a wide range of internal and external stakeholders and partners
- Ability to research and provide up to date Regulatory Intelligence for Russia and CIS
- Excellent organization and prioritization skills
Desirable Job Competencies
- Ability to work in a fast paced and changing environment
- Excellent problem solving skills and solution orientated outlook
- Ability to work in a Global Corporate environment
Additional Requirements
Откликнуться на эту вакансию: Sr. Specialist, Regulatory
Предыдущая вакансия:
Вакансия № 407968 на должность Врач акушер - гинеколог от компании Рузская районная больница, ГБУЗ МО в городе (населенном пункте) Истра