от компании (организации): ООО Nobel Biocare Russia в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Сертификация"
с заработной платой: по договоренности
Вакансия № 15924104 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Четверг, 10 октября 2024 года.
Дата обновления вакансии № 15924104 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 10 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 15924104 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: Regulatory Affairs Specialist
Primary Responsibilities:
- Responsible for all RA deliverable linked to the registration and certification of the medical devices in Russia, collecting the registration dossier for CIS region, 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. 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 in Russia.
- 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.
- Support in development and execution of regulatory strategies for assigned projects for product registration and maintenance in the CIS region.
- Accountable for regulatory compliance
- Assessment and regulatory implementation of change requests
- Review and approval of product related labeling
- Monitoring legislative environment in relevant markets
- Training internally on relevant procedures and requirements
- Support audits by competent authorities as well as internal audits
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 organisation
- 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
Откликнуться на эту вакансию: Regulatory Affairs Specialist
Предыдущая вакансия:
Вакансия № 15924098 на должность Бухгалтер на участок Расходы от компании Медипал в городе (населенном пункте) Москва