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6 дней назад

Specialist, Regulatory Affairs (Medical Devices)

Формат работы
remote (только Switzerland)/onsite
Тип работы
fulltime
Грейд
middle
Английский
c1
Страна
Switzerland
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
Specialist, Regulatory Affairs (Medical Devices): Managing EU regional product registrations, regulatory submissions, renewals, notifications, and EUDAMED activities for CE-marked medical devices with an accent on document control, registration accuracy, and cross-functional coordination. Focus on preparing national regulatory applications, maintaining approved records, and supporting global market approvals across EU, FDA, and UKCA requirements.

Location: Neuchâtel, Switzerland. The role is described as on-site and is also eligible for a remote work arrangement from home.

Company

hirify.global is a global medical technology company within Danaher that develops monitoring technologies, sensors, patient monitors, and connectivity solutions.

What you will do

  • Prepare and submit national regulatory applications across the EU region.
  • Process and maintain EU registrations, notifications, renewals, changes, and EUDAMED registrations.
  • Coordinate distributor letters, distribution agreements, powers of attorney, authorizations, product lists, and market histories.
  • Maintain regulatory records and databases in SharePoint, Salesforce, and Oracle Agile PLM.
  • Support customer service, marketing, and sales with global market approvals for product shipments.
  • Collaborate with cross-functional stakeholders and regulatory affairs colleagues across EU and global teams.

Requirements

  • 2–5 years of EU regulatory affairs experience in a medical device company.
  • Experience with EU regulatory requirements for CE-marked medical devices, ISO 13485, and EN ISO 14971.
  • Fluent English required.
  • Proficiency with document control systems, including SharePoint and Oracle Agile PLM.
  • Experience with global regulatory requirements such as FDA and UKCA.
  • Ability to work on-site in Neuchâtel, Switzerland, with remote work eligibility for this role.

Nice to have

  • Experience working with international corporations.
  • Experience collaborating with local and non-local leadership.
  • Strong documentation, record-tracking, and document traceability skills.

Culture & Benefits

  • Collaborative and international regulatory affairs environment.
  • Culture focused on belonging, continuous improvement, innovation, and tangible impact in life sciences.
  • Comprehensive benefits, including health care programs and paid time off.
  • Flexible remote working arrangements for eligible roles.

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