Jobs / engineering
Senior Regulatory Affairs Engineer
Elekta · Veenendaal
IND sponsor
What you will do
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.
What you will do
- 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 they look for
- 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