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Senior Regulatory Affairs Engineer

Elekta

Elekta

Klinisch-theoretische vakgebieden

Veenendaal, Utrecht - Niederlande

Senior specialist / Projectmanager

Thuiswerk

Experteer Overview

Senior Regulatory Affairs Engineer (Team Lead) at Elekta enables global market access for medical devices. You combine hands-on regulatory expertise with a coordinating role, supporting the team to ensure compliance and continuous improvement. You collaborate with cross-functional teams through the product lifecycle to meet international regulatory requirements. You lead and mentor colleagues, liaise with authorities, and drive process optimization in a dynamic, international setting. This role offers the chance to impact cancer care accessibility and quality on a global scale.

Arbeidsvoorwaarden / Benefits

  • 27 paid vacation days per year
  • 13 ATV days
  • Global bonus plan or Profit scheme
  • Travel allowance
  • Good pension fund 50/50
  • Insurance discounts

Verantwoordelijkheden

  • Ensure and maintain regulatory approvals and compliance across targeted markets
  • Prepare and submit regulatory documentation to governing authorities
  • Translate regulations into clear business requirements
  • Collaborate with cross-functional teams across the product lifecycle
  • Act as a senior point of contact and support and guide team members in day-to-day activities
  • Liaise with regulatory authorities and internal stakeholders
  • Drive continuous improvement and process optimization
  • Authorize regulatory documents and support audits and reporting

Belangrijkste vereisten

  • 5+ years’ experience in Regulatory Affairs (medical devices)
  • Experience with regulatory submissions and project management
  • Master’s degree in Engineering, Science, or similar
  • Strong knowledge of global regulations
  • Experience supporting, guiding, or mentoring colleagues in a team setting
  • Excellent communication skills in English
  • Proactive, structured, and detail-oriented
communicationmentoring/leadershipproactivityregulatory submissionsproject managementglobal regulatory knowledge

Functiebeschrijving

Senior Regulatory Affairs Engineer (Team Lead) at Elekta enables global market access for medical devices. You combine hands-on regulatory e…
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