от компании (организации): Align Technology в городе (населённом пункте): Москва, Россия
в отрасли экономики "Производство, сельское хозяйство" → "Фармацевтическая промышленность"
с заработной платой: по договоренности
Вакансия № 11429792 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 24 августа 2024 года.
Дата обновления вакансии № 11429792 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 № 11429792 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
The primary responsibilities include but are not limited to the following areas: executing the pre-market and post-market Regulatory Affairs activities and supporting the Head of Regulatory Affairs Russia.
Medical device Vigilance
Under the responsibility of the Head of Regulatory Affairs Russia, he/she executes Vigilance Reporting to Roszdravnadzor and other CIS authorities.
Product registration on new markets (Eurasia economic union, CIS)
He/she executes and/or supports product registrations (new product introductions or renewals of existing product registrations) to Roszdravnadzor in Russia and other Ministries of Health or other applicable medical device regulators, in compliance with the applicable regulations in the Russia and CIS countries. He/she monitors completion of advisory notices / corrections / market withdrawals / removals / recalls, and supports the head of Regulatory Affairs Russia that regulatory communication is timely executed.
Executes customer complaint resolution, and interfacing with outside regulatory agencies, under supervision of the Head RA.
Supports Head RA with ensuring compliance with the applicable country regulations and Align Technologies policies and procedures.
Supports with implementing and maintaining the Quality Management System in compliance with ISO 9001:2015, ISO 13485:2016 and Align Technology policies and procedures.
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).
- Supports any required filings for Medical Device and Safety Vigilance Reports within the defined time to Regulatory Agencies/ Competent Authority/Ministry of Health.
- Supports the Head RA Russia with communication internally with Align Technologies EMEA QA-RA team concerning reported incidents.
- Tracks status of reported incidents with Roszdravnadzor and other MoH ensuring all cases are close, following adequate submission of objective evidence.
Product Registrations
- Executes 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.
- Supports the coordination with Competent Authorities and/ or Authorized Representative for product Registrations.
- Tracks status of current and new product registrations and pro-actively informs when licenses will expire.
Recall & Correction Management
- Executes communication package localization. Proposes/executes Customer/Competent Authority communication to head RA Russia.
- Tracks product recalls for field safety corrective actions to closure.
- Informs Head RA Russia on closure of advisory notices / corrections / market withdrawals / removals / recalls, in the market.
Regulatory Affairs Management
- Assists 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
- Supports 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
ACADEMIC BACKGROUND
High medical, biological, pharmaceutical or chemical education / Quality Management degree or equivalent trainings are necessary.
MD vigilance or Pharmacovigilance trainings – as a plus.
REQUIRED EXPERIENCE
- 3-year minimum experience working in Medical Device, Pharma or life science Regulatory Affairs is a must.
- Having successfully completed product registrations in the applicable market / country.
- 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.
LANGUAGES
- Strong written and oral communication abilities required and ability to synthesize information to present as requested.
- Fluent English and local language(s) of the applicable market required (reading, writing, and conversation).
SKILLS /COMPETENCIES
- Must have good interpersonal skills and the ability to work cross-functionally.
- Understands commercial market needs.
- Must have very high level of commitment and a positive can-do attitude.
- Must be able to make good assessments on what can and cannot be accomplish before making commitments.
- Must be proficient with computers and standard software programs such as Microsoft.
- Must be able to work independently as well as in close collaboration with others.
- Attention to detail and ability to solve problems and communicate issues.
- Ability to work on multiple projects.
Откликнуться на эту вакансию: Regulatory Affairs Specialist
Предыдущая вакансия:
Вакансия № 11429783 на должность Руководитель по научно-технической поддержке производства (фармацевтическая отрасль) от компании ANCOR Consumer Goods в городе (населенном пункте) Москва