Regulatory Affairs Specialist
ElektaUtrecht, Netherlands
Posted November 20, 2025
Full Time
About the Company
At Elekta, our outcome-driven and cost-efficient solutions provide lasting clinical difference and are developed through sustainable environmental, social and governance practices. We’ve been working openly and proactively with clinicians and our partners for almost half a century to advance precision radiation therapy and meet continuously evolving patient needs—no matter where they are in the world. To us, it's personal, and our global team of 4,700 employees combine passion, science, and imagination to profoundly change cancer care. We don’t just build technology, we build hope. Elekta is headquartered in Stockholm, Sweden, with offices in 120 countries and listed on Nasdaq Stockholm. Visit elekta.com to learn more.
Job Description
Regulatory Affairs Specialist responsible for enabling market access for regulated medical devices. Supports local and global teams with regulatory submissions, responses to governing agency actions, and process improvements.
Requirements
- Proven experience in Regulatory Affairs for Medical Devices
- Degree in an engineering-related field or equivalent apprenticeship with relevant experience
- Strong understanding of product regulation and ability to translate into business requirements
- Structured problem-solving skills and a proactive mindset
- Excellent communication skills—written and verbal
- Ability to work independently and influence cross-functional teams
- Proficiency in Microsoft Office applications
- Comfortable working in a multicultural environment
- Positive attitude towards changes and collaboration
Benefits
- 27 paid vacation days per year plus 13 ATV days
- Global bonus plan or Profit scheme
- Travel allowance
- Good pension fund Metalektro, 50/50 payment
- Insurance discounts
- Active staff association
- Tax benefits for fitness centres and bicycle purchases