Senior Regulatory Affairs Engineer

Elekta

Áreas clínicas y teóricas

Veenendaal, Utrecht - Netherlands

Project Manager Sénior / Especialista sénior

Híbrido

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.

Compensaciones / Beneficios

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

Responsabilidades

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

Requisitos principales

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

communication mentoring/leadership proactivity regulatory submissions project management global regulatory knowledge

Descripción del puesto

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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