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5 дней назад

Senior Specialist, Regulatory Affairs (Medical Devices)

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
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
Senior Specialist, Regulatory Affairs (Medical Devices): Supporting regulatory strategy and compliance for hearing healthcare devices across global markets with an accent on EU MDR, MDSAP, market access, and product lifecycle activities. Focus on assessing regulatory requirements, preparing submissions and registrations, managing product changes, and translating complex regulations into practical guidance for cross-functional stakeholders.

Location: Ballerup, Denmark; flexible working is supported, with a need for in-person collaboration.

Company

A global hearing, audio, video, and gaming technology organization developing products that improve communication, accessibility, and user experiences.

What you will do

  • Support strategic initiatives within Regulatory Affairs and help maintain compliance for medical devices across global markets.
  • Contribute to regulatory assessments, submissions, registrations, and change management throughout the product lifecycle.
  • Focus on EU MDR and MDSAP market requirements and regulatory pathways.
  • Partner with R&D, Quality, and Commercial stakeholders to enable innovation and market access.
  • Translate complex regulatory requirements into clear guidance and support timely internal decision-making.

Requirements

  • Direct experience in Regulatory Affairs within a global medical device environment.
  • Solid knowledge of EU MDR and MDSAP compliance expectations and regulatory pathways.
  • Ability to combine strategic regulatory work with hands-on execution and delivery.
  • Strong collaboration and relationship-building skills across multidisciplinary teams.
  • Ability to communicate complex topics clearly and in an audience-appropriate format.

Nice to have

  • Experience with hearing healthcare products or other regulated healthcare technologies.
  • Relevant transferable skills, motivation, and a growth-oriented mindset.

Culture & Benefits

  • Flexible working is supported where possible, balanced with in-person collaboration.
  • Work in an experienced Regulatory Affairs team focused on quality, collaboration, and continuous improvement.
  • Cross-functional exposure across R&D, Quality, and Commercial functions.
  • Inclusive recruitment process with equal consideration for all applicants.
  • CVs without photos are encouraged to support an equal application process.

Hiring process

  • Submit an up-to-date CV and a few sentences explaining motivation.
  • Applications are assessed continuously until the position is filled, and the stated deadline is September 27, 2026.
  • Special interview requirements can be discussed when accepting the interview invitation.

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