от компании (организации): ООО Nobel Biocare Russia в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Лекарственные препараты"
с заработной платой: по договоренности
Вакансия № 2486250 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Пятница, 1 ноября 2024 года.
Дата обновления вакансии № 2486250 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 № 2486250 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
1–3 года
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Regulatory Affairs Specialist/Manager
Description
Are you looking to work for a Fortune 150 company that makes a profound impact on the world?
Nobel Biocare is part of the Danaher Corporation, a global science and technology innovator committed to helping its customers solve complex challenges and improving quality of life. We are a world leader in the field of innovative implant-based dental restorations. The company’s portfolio offers solutions from single tooth to fully edentulous indications with dental implant systems, a comprehensive range of high-precision individualized prosthetic and CAD/CAM systems, diagnostics, treatment planning and guided surgery solutions and bio materials. The company is headquartered in Zurich, Switzerland. Production takes place at six sites located in the United States, Sweden, Japan and Israel.
Reporting to the Global Head RA Nobel Biocare, the Regulatory Affairs Specialist will be employed and based in our Moscow office. We are looking for a strong candidate with communication and interpersonal skills, team-oriented, self-motivated, multi-task management and problem-solving abilities to provide support in following areas:
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 experience in regulatory affairs within the Medical Device Industry in Russia
- Understandign of EU medical Device regulations
About Us
We are a world leader in the field of innovative implant-based dental restorations. The company’s portfolio offers solutions from single tooth to fully edentulous indications with dental implant systems, a comprehensive range of high-precision individualized prosthetics and CAD/CAM systems, diagnostics, treatment planning and guided surgery solutions and biomaterials. We support customers through all phases of professional development, offering world-class training and education along with practice support and patient information materials. The company is headquartered in Zurich, Switzerland. Production takes place at six sites located in the United States, Sweden, Japan and Israel. Products and services are available in over 80 countries through subsidiaries and distributors.
We are a part of global science & technology corporation, which is an innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. With more than 20 operating companies, our globally diverse team of over 62,000 associates is united by a common culture and operating system. We generated $16.9B in revenue last year. We are ranked #144 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 years.
Откликнуться на эту вакансию: Regulatory Affairs Specialist/Manager
Предыдущая вакансия:
Вакансия № 2486248 на должность Администратор клиники от компании ООО ВИАЛ в городе (населенном пункте) Москва