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4 дня назад

Regulatory Affairs Specialist (Medical AI)

Формат работы
remote (Global)
Тип работы
fulltime
Английский
c1
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
Regulatory Affairs Specialist (Medical AI): Transform complex regulatory requirements into scalable solutions supporting AI medical device development and certification with an accent on ISO 13485 quality management and EU MDR compliance. Focus on preparing technical documentation, leading conformity assessments, and collaborating across interdisciplinary teams to ensure regulatory compliance and clinical value.

Location: Remote, work from anywhere

Company

hirify.global is a startup pioneering medical AI to maximize human health with a focus on innovation and a flexible, remote-friendly culture.

What you will do

  • Own and continuously improve the ISO 13485-certified Quality Management System.
  • Lead MDR conformity assessments and manage interactions with the Notified Body.
  • Prepare technical documentation for AI-powered medical devices.
  • Act as the regulatory partner for interdisciplinary product teams.
  • Support audits, risk management, and continuous improvement activities.

Requirements

  • Professional proficiency in English and German (written and spoken).
  • Experience in Regulatory Affairs for medical devices, ideally under the EU MDR.
  • Bachelor's or Master's degree in Life Sciences, Medical Technology, Biomedical Engineering, Regulatory Affairs, or related field.
  • Strong written communication and analytical thinking skills.
  • Ability to work independently and collaborate effectively across teams.

Nice to have

  • Enthusiasm for digital health, AI, and innovative medical technologies.

Culture & Benefits

  • Support for growth through regular feedback and meaningful work.
  • Autonomy, flexibility, and collaboration with capable colleagues.
  • Flexible, remote-friendly team culture with regular company retreats.
  • Fair compensation.

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