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
- communication
- mentoring/leadership
- proactivity
- regulatory submissions
- project management
- global regulatory knowledge
Senior Regulatory Affairs Engineer in Veenendaal werkgever: Jobrapido
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