от компании (организации): KaVo Dental Russland GmbH в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Медицинский советник"
с заработной платой: по договоренности
Вакансия № 286550 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 14 сентября 2024 года.
Дата обновления вакансии № 286550 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 № 286550 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: Director of Regional Regulatory Affairs
Director of Regional Regulatory Affairs, Dental platform, Russia&CIS
is responsible for performing regional registrations, establishing new registration routes by creating local representation. He/she will lead a team of local associates covering registration needs, regulatory intelligence, adverse event reporting and field corrective actions of wide range of dental products of variety of dental brands.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Researching local regulatory framework and providing market regulatory expertise to all the operating companies within dental platform
- Ensures that resources and activities are aligned with the commercial objectives. Effectively communicates progress, problems, and plans.
- Responsible for registrations of new and existing products
- Manages and develops team of Regulatory professionals.
- Provides appropriate mentoring, appraisals, and discipline of direct reports.
- Manage registration portfolio through daily management and track on-time delivery of registration projects
- Collaborate with dealers and local governments on registrations and registration maintenance
- Evaluate dealers and other third parties for capability to act on company behalf in local registrations
- Collaborating with operating companies on labeling translations
- Assessing impact of product design changes on local registrations
- Assist in the regulatory review of product labels, literature and websites
- Collaborate with operating companies on adverse effects reporting, field corrective actions
- Provide updates to stakeholders
- Create an environment that attracts, develops, and retains high quality employees, foster employee engagement, diversity, professional development and high levels of employee satisfaction.
- Participates in audits and inspections of the company and its quality systems.
- Manage departmental budget
REQUIREMENTS:
- Minimum of Bachelor's Degree, higher education preferred.
- 8+ years’ experience working in medical device regulatory environment in the region
- 3+ years of experience managing RA/QA associates.
- Ability to travel up to 25% of the time
- Fluent English both written and spoken
PREFERRED SKILLS:
- Knowledge of secondary language(s) is a strong plus
- Direct experience with preparing and submitting materials for local regulatory agencies.
- Good knowledge of regional governmental policies and culture
- Strong management skills, ability to manage resources located in different geographies
- Ability to identify, research, and analyze technical documentation and governmental regulations
- Strong work ethics, ability to manage change, ability to organize complex work, conduct problem solving
- Strong communication skills both written and verbal.
- Ability to conduct root cause investigation of misses and track progress of countermeasures
Откликнуться на эту вакансию: Director of Regional Regulatory Affairs
Предыдущая вакансия:
Вакансия № 286508 на должность Медицинский регистратор/Администратор-кассир от компании ООО НАШ ДОКТОР в городе (населенном пункте) Москва