Global Regulatory Affairs Lead, Medical Devices

Elekta AB; Netherlands; Hybrid; 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

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.