Regulatory Affairs Specialist

We don’t just build technology. We build hope for everyone dealing with Cancer. 

At Elekta, we believe every individual deserves access to the best cancer care. That’s why we’re committed to developing innovative solutions that make precision radiation therapy and radiosurgery more effective, efficient, and accessible. If you're passionate about making a meaningful impact, we invite you to bring your expertise and energy to our team. 

This role is based in Veenendaal, Netherlands.

What you’ll do at Elekta 

As a Regulatory Affairs Engineer, you will play a vital role in enabling market access for our regulated medical devices. You’ll work across local and global teams to do regulatory submissions, respond to governing agency actions, and help define and improve processes that ensure compliance and quality. 

Responsibilities 

• Prepare and release regulatory submissions to governing agencies. 

• Collaborate with cross-functional teams to define processes and identify system impacts.  

• Authorize documents and forms related to regulatory activities.  

• Plan and execute audits, including preparation of audit reports.  

• Issue and update processes and procedures.  

• Provide timely and accurate project reports.  

• Driving change and continuous improvement initiatives.  

• Offer creative solutions and proposals to solve business challenges.  

• Align priorities and manage change effectively. 

• Commit to quality and integrity in all aspects of work.

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What You Bring 

• 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 

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We encourage you to apply even if you don’t meet every requirement—your unique skills and experiences might be exactly what we're looking for!   

Why should you join Elekta? 

In this role, you will work for a higher purpose; hope for everyone dealing with cancer, and for everyone regardless of where in the world, to have access to the best cancer care. You will be part of our international innovative team and given the opportunity to learn and develop.   

Overview of some of our benefits for Veenendaal are as below.  

• 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   

• Hybrid work option (you are required to work on location at least 3 days/week)  

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Hiring process 

We are looking forward to hearing from you! Apply by submitting your application and resumé in English, via the “Apply” button. Please note that we do not accept applications by e-mail.  

Your Elekta contact 

For questions, please contact the responsible hiring manager, Matilda Forsberg, matilda.forsberg@elekta.com.  

We are an equal opportunity employer 

We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, genetic information, national origin, disability, veteran status, or any other status protected by law in the locations where Elekta operates. 

About Elekta 

Here at Elekta, you will make a difference. We are a MedTech company that provides software and hardware to hospitals and clinics all over the world. 

We have a responsibility toward our partners and customers to deliver solutions in a secure and sustainable way. Both when it comes to financial and environmental matters, but also for our employees to feel that they bring value, wherever in the organization they may work.