Regulatory Affairs Specialist

Elekta AB; Veenendaal; Hybrid; EUR 65,000 - 110,000; Full time

Benefits offered by this job

Vacation days

Bonus plan

Travel allowance

Pension

Insurance discounts

Staff association

Tax benefits

Hybrid work

Job summary

Elekta is seeking a Regulatory Affairs professional to support medical devices in a global setting. You will prepare regulatory submissions, interact with cross-functional teams, and ensure compliance across processes. The role emphasizes audits, change control, and documentation quality.

Based in the Netherlands, you’ll work on-site at least 3 days per week with hybrid flexibility, contributing to a culture of quality, collaboration, and continuous improvement.

Qualifications

• Regulatory affairs experience in medical devices.
• Ability to translate product regulation into business requirements.
• Excellent written and verbal communication to interact with cross-functional teams.

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.
• Drive change and continuous improvement initiatives.
• Offer creative solutions to business challenges.
• Align priorities and manage change effectively.
• Commit to quality and integrity in all work.

Skills

Regulatory affairs

Education

Engineering-related degree or apprenticeship

Job description

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.

Location: Veenendaal, Netherlands.

What you’ll do at Elekta

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.

Benefits

• 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).

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.