Senior Regulatory Affairs Engineer

Elekta AB; Netherlands; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

27 paid vacation days per year

Global bonus plan

Travel allowance

Pension fund

Insurance discounts

Active staff association

Tax benefits for fitness centres and}

Hybrid work option (on-site 4 days/wk)

Job summary

Elekta in the Netherlands seeks a Senior Regulatory Affairs Engineer (Team Lead) based in Veenendaal. You will enable global market access for our medical devices by combining hands-on regulatory expertise with a coordinating role across cross-functional teams.

You will lead regulatory submissions, maintain approvals, mentor colleagues, and drive continuous improvement while ensuring compliance with international requirements.

Qualifications

• 5+ years of regulatory affairs experience in medical devices.
• Experience with regulatory submissions and project management.
• Master’s degree in Engineering, Science, or similar.
• Strong knowledge of global regulations.
• Experience mentoring or guiding colleagues in a team.
• Excellent English communication skills.
• Proactive, structured, and detail-oriented.

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.

Skills

Regulatory Affairs

Regulatory submissions

Project management

Team mentoring

English communication

Attention to detail

Education

Master’s degree in Engineering/Science

Job description

Are you a current Elekta employee? Please click here to apply through our internal career site Find Jobs - Elekta. We don’t just build technology. We build hope for everyone dealing with Cancer. 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 4,000 employees and offices in more than 40 countries. The company is listed on Nasdaq Stockholm. For more information, visit elekta.com. 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.

Senior Regulatory Affairs Engineer (Team Lead)

What you’ll 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 team’s daily priorities contributing to compliance and continuous improvement. You’ll 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
• Master’s 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 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 4 days/week)

Our Elekta contact For questions, please contact the responsible hiring manager, MatildaForsberg,[e-mail].

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.

As a leader in precision radiation therapy, Elekta is committed to ensuring every patient has access to the best cancer care possible. We openly collaborate with customers to advance sustainable, outcome‑driven and cost‑efficient solutions to meet evolving patient needs, improve lives and bring hope to everyone dealing with cancer. 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 more than 120 countries and listed on Nasdaq Stockholm.

For more information, visit elekta.com or follow us on LinkedIn, Glassdoor, Twitter, Facebook, Instagram and YouTube.