от компании (организации): Abbott Laboratories в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Сертификация"
с заработной платой: по договоренности
Вакансия № 4837642 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Четверг, 17 октября 2024 года.
Дата обновления вакансии № 4837642 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 № 4837642 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
более 6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Regulatory Manager (Russia & CIS)
Overview of the position:
For the Abbott Rapid Diagnostics Infectious Disease - Emerging Markets Business Unit, responsibility for RA activities in the RCIS geography relating to
- products distributed by ARDx in Russia;
- products distributed by ARDx in CIS countries.
Key Responsibilities:
- Develops registration plans for the region in collaboration with manufacturing sites, regional marketing, commercial affiliates and Distributor countries marketing;
- Ensures execution of registrations of products in alignment with regulatory plans;
- Actively participates in short and long-range planning including the development of Key Performance Indicators;
- Manages the budget and resources of the regional regulatory activities to ensure fulfilment of the goals of the company;
- Promotes awareness of regulatory and customer requirements throughout the organisation, including through organised training programmes;
- Ensures compliance of ARDx Russia and distributors in CIS with IVD Directive, US FDA requirements and WHO PQ guidances;
- Supports sites in contact with National Regulatory Agencies;
- Represents RA RCIS at relevant leadership meetings;
- Represents RA RCIS in relevant Industry forums;
- Supports business operations in adverse event reporting;
- Supporting business operations in product modification reporting;
- Facilitates gathering of regulatory intelligence;
- Upholds the company’s core values.
Requirements:
- BSc or equivalent.
- Training in Regulatory Affairs.
- Relevant experience at a senior level.
- A minimum of 5 years’ experience in areas directly relevant to the position
- Ability to develop and manage high performing teams to achieve desired outcomes.
- Demonstrated capacity to successfully execute strategies designed to achieve an appropriate return on investment for the business.
- Demonstrable working knowledge of the medical diagnostics industry.
- Understanding of Quality and Quality Management systems (ISO 13485, ISO 9001 and US FDA QSR)
- Knowledge of the requirements of industry regulators.
- Knowledge of the RCIS regulatory environment.
- Capacity to apply sound judgement for the effective management of the company’s resources and personnel.
- Capacity to identify strategic opportunities and recognise threats.
- Ability to travel frequently within RCIS and globally.
- Excelent written and oral communication skills in English and Russian and an ability to prepare competent business cases.
- Strong mission orientation.
- Attention to detail.
- Strong interpersonal skills.
- Highest levels of integrity and diplomacy.
- Capacity to maintain the highest levels of confidentiality internally and externally.
Откликнуться на эту вакансию: Regulatory Manager (Russia & CIS)
Предыдущая вакансия:
Вакансия № 4837641 на должность IOS разработчик от компании ООО Сравни.ру в городе (населенном пункте) Москва