Regulatory Affairs Specialist

Reposted 6 Days Ago
Be an Early Applicant
Veenendaal, NLD
In-Office
Mid level
Healthtech • Biotech
The Role
The Regulatory Affairs Specialist will manage regulatory submissions, collaborate with teams, ensure compliance, conduct audits, and drive process improvements.
Summary Generated by Built In
Are you a current Elekta employee?  

Please click here to apply through our internal career site Find 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!

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.

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 

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)  

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. 

 

Skills Required

  • Proven experience in Regulatory Affairs for Medical Devices
  • Degree in an engineering-related field or equivalent apprenticeship
  • Strong understanding of product regulation and translating 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

Elekta Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Elekta and has not been reviewed or approved by Elekta.

  • Retirement Support A 401(k) with employer match is a prominent benefit, with vesting noted as part of the plan.
  • Leave & Time Off Breadth PTO and paid holidays are included, with PTO accruing from the start and rollover allowed within limits.
  • Healthcare Strength Medical, dental, vision, life and disability coverage are included, complemented by an Employee Assistance Program.

Elekta Insights

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The Company
HQ: Stockholm
4,700 Employees
Year Founded: 1972

What We Do

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.

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