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4 дня назад

Assistant Regulatory Affairs Manager (Medical Devices)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
China
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Assistant Regulatory Affairs Manager (Medical Devices): Managing registration projects, certificates, and regulatory documentation for non-active implantable medical devices with an accent on authority coordination and regulatory compliance. Focus on completing Class III implantable device registrations, tracking regulatory changes, and maintaining registration archives in China.

Location: Onsite in China

Company

hirify.global develops healthcare solutions focused on protecting and improving people’s health worldwide.

What you will do

  • Manage registration projects for non-active implantable medical devices.
  • Communicate and coordinate with regulatory authorities.
  • Track regulatory trends and changes to applicable standards.
  • File, manage, and archive registration documents and certificates.

Requirements

  • Bachelor’s degree or higher in a science- or engineering-related field; a master’s degree is preferred.
  • Bilingual English and Chinese communication skills are required.
  • At least 8 years of experience in medical device registration.
  • At least three successful registrations of Class III implantable medical devices.
  • Experience with at least two active medical device projects, supported by documented evidence.

Culture & Benefits

  • Work in a healthcare-focused environment centered on trust, transparency, appreciation, innovation, efficiency, and sustainability.
  • Contribute to healthcare development and regulatory compliance in China.

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