Regulatory Affairs Specialist

Are you a current Elekta employee?  

Please click here to apply through our internal career siteFind Jobs - Elekta.

Want to join a team with a mission to improve and save lives?  

We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their communities.

We currently have the following opportunity available - please contact us for more details!

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

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

This role is based inVeenendaal, Netherlands.

Whatyou’ll do at Elekta 

As aRegulatory Affairs Engineer, you will play a vital role in enabling market access for our regulated medical devices.You’ll work acrosslocal andglobal teams todoregulatory 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 andidentify 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.  

• Providetimely andaccurate 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 towardschanges and collaboration 

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We encourage you to apply even if youdon’t meet every requirement—your unique skills and experiences might be exactly whatwe'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 ofwhere in the world, to have access to the best cancer care. You will be part of ourinternational innovative team and given the opportunity to learn and develop.   

Overview of some of our benefits forVeenendaalare as below.  

• 27 paid vacation days peryear  plus 13 ATV days 

• Global bonus plan or Profit scheme  

• Travel allowance  

• Good pension fundMetalektro, 50/50 payment  

• Insurance discounts  

• Active staff association  

• Tax benefits for fitnesscentres and bicycle purchases   

• Hybrid workoption (youare 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 bysubmitting 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.