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8 дней назад

Student Assistant (Quality Assurance and Regulatory Affairs) (AI/MedTech)

Формат работы
onsite
Тип работы
parttime
Грейд
trainee
Английский
b2
Страна
Denmark
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
Student Assistant (Quality Assurance and Regulatory Affairs) (AI/MedTech): Supporting quality and regulatory activities for Software as a Medical Device products in radiology with an accent on market registrations, ISO standards, and Quality Management System records. Focus on communicating with authorities, maintaining CAPA and change-control documentation, and improving regulated quality processes.

Location: Aarhus, Denmark; part-time role

Company

hirify.global develops Software as a Medical Device products that apply Machine Learning and AI to radiology.

What you will do

  • Support product registrations in new markets and communicate with relevant authorities.
  • Create and maintain Quality Management System records for CAPA, change control, customer complaints, and training.
  • Review and revise QMS procedures to improve their efficiency and effectiveness.
  • Drive projects that improve quality and regulatory processes.

Requirements

  • Background in molecular biology, health technology, or a related field.
  • Currently completing a degree, with an expected graduation timeline of 2–3 years.
  • Interest in developing a career in Quality Assurance, Regulatory Affairs, or health-tech project management.
  • Structured, responsible, and able to work independently and collaboratively.
  • Willingness to learn how to develop and maintain a QMS in a regulated industry and support medical-device market entry.

Nice to have

  • Familiarity with ISO 13485, ISO 62304, ISO 82304, or Good Manufacturing Practice.
  • Experience with medical-device regulations.

Culture & Benefits

  • Opportunity to develop practical skills in Quality Assurance and Regulatory Affairs within the health-tech ecosystem.
  • Exposure to ISO standards, regulations, market registrations, and Software as a Medical Device products.
  • Part-time work suitable for a student in Aarhus.

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