Regulatory Affairs Specialist

Elekta; Veenendaal; Hybrid; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid work option (on-site at least 3

Travel allowances

Global bonus plan

Pension fund

Insurance discounts

Active staff association

Tax benefits for fitness and bicycles

Vacation and ATV days

Job summary

Elekta in the Netherlands (Veenendaal) is seeking a Regulatory Affairs Engineer to enable market access for regulated medical devices. You will work with local and global teams to prepare regulatory submissions, respond to agency actions, and help define processes to ensure compliance and quality.

This role offers collaboration across functions, audits, change initiatives, and ongoing improvement. You will translate regulatory requirements into actionable business needs and influence

Qualifications

• 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.

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.

Skills

Regulatory affairs

Engineering degree

Regulation knowledge

Problem solving

Communication

Independent / cross-functional

MS Office

Multicultural work

Collaborative mindset

Education

Engineering degree or equivalent apprenticeship

Tools

Microsoft Office

Job description

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

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.

Benefits

• 27 paid vacation days per yearplus 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)

Your Elekta contact

For questions, please contact the responsible hiring manager, Matilda Forsberg, [e-mail].

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.