Специалист по регистрации медицинских изделий

З/п не указана

Опыт работы: От 3 до 6 лет

График работы: Полный день

Занятость: Полная занятость

Компания: Nobel Biocare Russia

Обязанности:

Responsible for all RA deliverable linked to the registration and certification of the medical devices in Russia/EAEU/CIS, collecting the registration dossier, maintenance of registrations in Russia and other countries of the CIS region as assigned by his/her direct manage.
Supporting development and execution of regulatory strategies for assigned projects for Russia/CIS. This will include the creation of submission dossier compilation of documentation and managing of timelines.
Monitoring submission timelines and timely responses to requests competent authorities or other partners involved in product registration. It also includes constant support for the development/ improvement of RA processes for efficient product registration.
Support change projects by providing RA impact assessments and support defining the necessary activities on local level.
Monitoring of the medical device legislation in Russia and define and maintain an overview of the regulatory requirements and changes in the areas.
Support in training other departments to ensure continued compliance and timely market release in Russia.
Accountable for regulatory compliance
Review and approval of product related labeling
Training internally on relevant procedures and requirements
Support audits by competent authorities as well as internal audits

Требования:Critical Education and Knowledge:

Technical or scientific background, university degree is an advantage
Working knowledge of medical device legislation in Russia and corresponding guidelines
Additional knowledge of legislation in other countries of the CIS region is of advantage
Understanding of the European CE marking process
Good knowledge of quality system requirements such as ISO 13485
Additional knowledge of software development requirements (IEC 62304 and ICE 62366) as well as standards for electrical products such as IEC 60601 are an advantage.
SAP

Critical Skills:

Fluent in Russian and English (writing, reading and speaking), further languages are an advantage
Highly organized and able to work under deadlines
Strong interpersonal skills and proactive working attitude in a international matrix organization
Excellent writing and communication skills

Critical Experience:

Minimum 3 years experience in regulatory affairs within the Medical Device Industry in Russia
Understanding of EU medical Device regulations

Условия:

Хочу откликнуться

Подработки в крупных торговых сетях рядом с домом по удобному графику.

Кассир во ВкусВилл в среднем 43 300 руб.

Консультации покупателей, работа с кассой. Фирменная одежда, обучение, компенсации, карьерный рост.

Сбор товаров, контроль продуктов, инвентаризация. Фирменная одежда, обучение, компенсации, карьерный рост.

Развитие и раскрутка новых магазинов в Москве, Московской области и других регионах России

Готовить вкуснейшие вопперы и другие позиции из меню ресторана. Быстро и аккуратно собирать заказы. Вести расчет по кассе.

Стабильность, обучение, премии, карьерный рост.

Раздача рекламных листовок, активное привлечение покупателей, работа с рупором. Обучение, фирменная спецодежда.