от компании (организации): Abbott Laboratories в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Сертификация"
с заработной платой: по договоренности
Вакансия № 16619954 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Пятница, 9 августа 2024 года.
Дата обновления вакансии № 16619954 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 № 16619954 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 Manager (Abbott Molecular Division)
Abbott Molecular Diagnostics is an emerging leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level. We are committed to exploring new clinical frontiers through the development and delivery of system and assay solutions that are designed to provide earlier disease diagnosis, selection of appropriate therapies and monitoring of disease recurrence. Our expanding portfolio brings multiples technologies that enable fast, accurate results. Our state-of-the-art research and manufacturing facilities have hundreds of scientists who are dedicated to producing quality and reliable products.
Regulatory Affairs Manager AMD will develop and manage products Registration strategy implementation within Abbott Molecular Division to accomplish planned objectives such as new innovative molecular platform registration, including reagents and consumables; obtain Registration for projects in pipeline; follow up Remediation Plan Global initiative; be responsible for hiring and leading a project team as a manager with direct reports.
The geographical coverage includes Russia and CIS, the position will be based in Moscow, Russia.
Major Job Objectives with subtasks
1. Drive registration projects in accordance with defined strategic plan to contribute in business growth in 2021 and beyond
It will be achieved through:
- Build and execution registration strategy for new molecular platform, mapping project implementation including instrument and samples availability, placement in the market, trials preparation, benchmarks to follow up with protocols and dossiers for submission
- Manage project budget and resources to execute strategies designed to achieve a return on investment for the business
- Be an expert in registration dossier and all related documentation preparation in line with strategic plan and changing local regulations. Understand 11N rules and EAC process, timeline and costs
- Monitor and timely reflect the risks of MOH local legislation and regulatory normative changes. Prepare and run the actions to address
- Work individually as well as forming, training a coherent team of regulatory specialists with dedication for performance, strong commitment on projects to complete on time and aligned with their Key Performance Indicators
- Become main contact for Global Regulatory, AQR team to promote awareness of regulatory and customer requirements throughout the organization
- Keep internal tracking, retention and audit accessibility of registration documents, reflect internal changes, notifications monitor in accordance with AQR requirements
2. Act as an industry regulation and product expert, being able to present company products and solutions
It will be achieved through:
- Become familiar with products portfolio, PCR and FISH molecular methods
- Become main contact for local regulators including institutions, opinion leaders, relevant agencies, labs and clinical sites involved in the process. Represent AMD in regulatory events enhancing the Company's and AMD image in the medical community
- Play an active role to notify the team, partners, regulatory body and other market participants regarding AMD products modification and changes
- Ensure all products provided to the market packed, contain latest approved IFU and labelled in accordance with local legislation requirement
3. Work closely with the regional team (commercial, admin/quality, application specialist and service team) contributing on a harmonized regional approach
It will be achieved through:
- Run regular registration status review with the team and regional management, ensure registration plan commitment and RA team focus for the year and subsequent period
- Ensure certificates needed access for commercial team, provide notifications timely and clarification letters on business request
Qualifications, Critical Skills and Experience
- Result oriented individual with ability to meet short and mid-term objectives
- Evidence indicates person was in the top, handled big stretch roles with proved successful registration completion record
- Set standards sought out and recognized leader with ability to persuade, motivate, coach and lead a team of regulatory specialists
- Proved ability in complex projects handling, takes initiative to do more, faster & better
- Eager to learn, constantly focus on self-improvement and self-development
- Working knowledge and familiarity with medical device industry regulatory policies and procedures latest changes including EAC
- Familiar with Quality and Quality Management systems (ISO 13485, ISO 9001 and US FDA QSR)
- Documented record of delivering regulatory related information from the market which adds value to management's decision-making process. Maintain the highest levels of confidentiality internally and externally
- Proved working relationships with local regulatory body, labs accredited for trials, related agencies, KOLs, and other regulatory stakeholders
- Strong organizational and follow-up skills, as well as attention to details
- Demonstrated verbal and written communication, negotiation, sales, interpersonal and presentation skills (Fluency in both English and Russian)
- Ability to work in a highly matrixed and geographically diverse business environment
- Ability to work as a team leader, within a team and as an individual contributor
- High sense of urgency
- Ability to multitask, prioritize and meet deadlines in a timely manner
- High standards of ethics and compliance
- High degree level (Molecular, Life Science, Medical are preferable)
- Personality with a minimum of 7-8 years of experience in relevant RA roles and leader/senior level position in healthcare industry with documented success
Откликнуться на эту вакансию: Regulatory Affairs Manager (Abbott Molecular Division)
Предыдущая вакансия:
Вакансия № 16619949 на должность Главный инженер проекта по инженерии от компании Битэкс, Строительная компания в городе (населенном пункте) Москва