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5 дней назад

Regulatory Product Surveillance Specialist (Medical Devices)

Формат работы
hybrid
Тип работы
fulltime
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
Regulatory Product Surveillance Specialist (Medical Devices): Supporting post-market surveillance, vigilance reporting, and clinical compliance for hearing solutions with an accent on medical device regulations, safety assessments, and complaint handling. Focus on evaluating product safety, providing clinical input for risk management decisions, and maintaining audit readiness.

Location: Ballerup, Denmark; flexible working with in-person collaboration

Company

Develops intelligent hearing, audio, video, and gaming solutions, including products that support people with hearing loss.

What you will do

  • Manage safety-related customer feedback and support complaint handling.
  • Prepare MDR and vigilance reports within the applicable regulatory framework.
  • Maintain compliance of post-market surveillance and vigilance procedures.
  • Perform clinical assessments supporting product safety and regulatory decisions.
  • Provide medical input for risk management decisions.
  • Participate in audits and inspections and support ongoing audit readiness.

Requirements

  • Healthcare professional qualification such as medical doctor, clinical scientist, audiologist, or equivalent.
  • Experience as a medical advisor, medical consultant, or in a similar role.
  • Strong knowledge of medical device regulations and applicable standards.
  • Ability to work independently and collaborate in multidisciplinary settings.
  • Clear and confident written and spoken English.

Culture & Benefits

  • Flexible working is supported where possible, balanced with in-person collaboration.
  • Collaborative, quality-focused environment with continuous learning and respectful dialogue.
  • Inclusive recruitment process with equal consideration for all applicants.
  • Interview accommodations are available upon request.

Hiring process

  • Submit an up-to-date CV and a few sentences describing motivation.
  • Applications are reviewed continuously until the role is filled, with applications requested by September 28, 2026.

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