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Абботт Україна — вакансия в Regulatory Affairs Specialist Medical Devices
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Regulatory Affairs Specialist Medical Devices

Абботт Україна
2 года назад
08 июля 2021
Киев

ABBOTT is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

We are looking for Regulatory Affairs Specialist Medical Devices

Main responsibilities:

  • Responsibility for developing a comprehensive registration strategy in the countries of responsibility Ukraine in close cooperation with the personnel dealing with sales, operations and marketing, taking into consideration Company's interests and normative requirements.
  • Responsibility for insuring earliest possible registration of all new or in-line products, along with the re-registration/making changes according to adopted registration strategies (and company's high ethical standards policy).
  • Reviewing registration files and all related documentation of the Company's products and preparing such documentation in line with local normative regulations.
  • Preparing Application Forms and other documentation for filing and registration of new products. Ensuring that all documentation, samples, commercial packs and other items are provided to relevant agencies as needed.
  • Establishing and maintaining good working relationships with all involved regulatory and other institutions. Keeping track of new regulations related to registration of medical devices.
  • Cultivating best possible relations with local regulatory providers and opinion leaders and enhancing the Company's image in the medical community in general.
  • Handling all issues related to changes in the Company's products status and performing regulatory related surveys in the country.
  • Preparing and reviewing package labels and inserts for Company's respective new and in-line products registered in the country.

Requirements:

  • Higher education
  • 2 years of experience in Regulatory Affairs (medical devices, pharmaceuticals) as a plus
  • Strong willing to develop in medical devices  regulatory affairs field;
  • English - written, spoken (Upper-Intermediate)
  • Excellent knowledge of MS Office (Word, Excel)
  • Personality: team player, well organized, attentive to details, enthusiastic, quick learner
  • Ability to work with big amount of information.

If you are interested in this opportunity, please do not hesitate to reach out and apply with your CV.

Абботт Україна — вакансия в Regulatory Affairs Specialist Medical Devices: фото 2

Компанія Abbott є світовим лідером у сфері охорони здоров’я.

больше 500  сотрудников

с 1982 года  на рынке

  • Офис в центреОфис в центре
  • Медицинское страхованиеМедицинское страхование
  • Бонусы и премииБонусы и премии
  • Регулярный пересмотр зарплатыРегулярный пересмотр зарплаты
  • Компенсация путешествийКомпенсация путешествий

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