от компании (организации): Align Technology в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Сертификация"
с заработной платой: по договоренности
Вакансия № 14297212 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 17 августа 2024 года.
Дата обновления вакансии № 14297212 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 22 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 14297212 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 Affairs Specialist (medical device)
MAIN RESPONSIBILITIES/DUTIES
Regulatory Affairs Administration
- Supports tracking of Quality Management System related Regulatory affairs KPIs to ensure compliance for the market.
Post-Market Surveillance/ Vigilance (reportable complaints or other regulatory cases).
- Support any required filings for Medical Device and Safety Vigilance Reports within the defined time to Regulatory Agencies/ Competent Authority/Ministry of Health.
- Support the Head RA Russia with communication internally with Align Technologies EMEA QA-RA team concerning reported incidents.
- Track status of reported incidents with Roszdravnadzor and other MoH ensuring all cases are close, following adequate submission of objective evidence.
Product Registrations
- Execute country / district Medical Product Approvals process and submissions when relevant – product notification and registration, if applicable, as per local countries requirement and according the RA plan as defined by Head RA Russia
- Prepare product registration documentation.
- Support the coordination with Competent Authorities and/ or Authorized Representative for product Registrations.
- Track status of current and new product registrations and pro-actively informs when licenses will expire.
Recall & Correction Management
- Execute communication package localization. Proposes/executes Customer/Competent Authority communication to head RA Russia.
- Track product recalls for field safety corrective actions to closure.
- Inform Head RA Russia on closure of advisory notices / corrections / market withdrawals / removals / recalls, in the market.
Regulatory Affairs Management
- Assist the Head RA Russia with public relations efforts on regulatory issues, i.e. governmental efforts, Regulatory Warning letters and product recalls.
- Keep aware of Regulatory requirements/ changes impacting the assigned country / districts and track regulatory intelligence.
Quality Assurance
- Support implementation and maintenance of effective and efficient QMS in compliance with ISO 9001:2015 and ISO 13485:2016, and 2016 and Align Technology policies and procedures
REQUIREMENTS/QUALIFICATIONS
- 6+ years’ experience as Regulatory Affairs specialist.
- High medical, biological, pharmaceutical or chemical education / Quality Management degree or equivalent trainings are necessary.
- 3-year minimum experience working in Medical Device, Pharma or life science Regulatory Affairs is a must.
- Spoken English
- Having successfully completed product registrations in Russia and CIS.
- Have had interactions with medical device regulators in applicable market.
- Extensive knowledge of Russian Medical device regulations, ISO 13485:2016, ISO 9001:2015 and other relevant market specific regulation.
WE OFFER
- Competitive salary and annual bonuses
- Professional development and career growth, trainings, English classes
- Voluntary Medical Insurance for all employees and their children (with dental treatment)
- Lunch allowance, corporate phone and SIM card
- 31 vacation days, paid sick leave
- Gym in the office, sports allowance
- Corporate events for employees and their children
- Office located in the loft-quarter "Danilovskaya Manufacture"
Откликнуться на эту вакансию: Regulatory Affairs Specialist (medical device)
Предыдущая вакансия:
Вакансия № 14297210 на должность Инженер-разработчик (химик) от компании ООО НПФ «ВИНАР» в городе (населенном пункте) Мытищи