Senior Regulatory Affairs Engineer

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Elekta is shaping the standard of care together with healthcare providers by developing precision radiation medicine that brings advanced radiotherapy into routine clinical practice. Our solutions support consistent efficient and personalized care addressing evolving patient needs. Through adaptive radiotherapy precision treatment delivery and integrated workflows Elekta supports care teams across a range of clinical settings. Each year more than 2 million patients are treated using Elekta solutions across over 130 countries. Elekta is headquartered in Stockholm Sweden with over 4000 employees and offices in more than 40 countries. The company is listed on Nasdaq Stockholm. For more information visit.

We dont just build technology. We build hope for everyone dealing with Cancer.

At Elekta we believe every individual deserves access to the best cancer care. Thats why were committed to developing innovative solutions that make precision radiation therapy and radiosurgery more effective efficient and accessible. If youre 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.

Senior Regulatory Affairs Engineer (Team Lead)

What youll do at Elekta

As a Senior Regulatory Affairs Engineer (Team Lead) you will play a key role in enabling global market access for our medical devices. You combine hands-on regulatory expertise with a coordinating role while supporting the teams daily priorities contributing to compliance and continuous improvement.

Youll work closely with cross-functional teams to ensure products meet international regulatory requirements and are successfully introduced and maintained in global markets.

Responsibilities

• 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

What You Bring

• 5 years experience in Regulatory Affairs (medical devices)
• Experience with regulatory submissions and project management
• Masters 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

What Makes You Successful

• You are committed to quality and integrity
• You proactively drive change and improvement
• You bring creative solutions to complex challenges
• You thrive in a dynamic international environment

We encourage you to apply even if you dont meet every requirementyour unique skills and experiences might be exactly what were 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.

• 27paid vacation days peryearplus13 ATV days
• Global bonus plan or Profit scheme
• Travel allowance
• Good pension fundMetalektro 50/50 payment
• Insurance discounts
• Active staff association
• Tax benefits for fitnesscentresand bicycle purchases
• Hybrid workoption(youare required towork on location at least 4 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

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.