We don’t just build technology.
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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.
Elekta is headquartered in Stockholm, Sweden, with over 4,000 employees and offices in more than 40 countries.
We don’t just build technology.
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 ElektaAs 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.ResponsibilitiesEnsure and maintain regulatory approvals and compliance across targeted marketsPrepare and submit regulatory documentation to governing authoritiesTranslate regulations into clear business requirementsCollaborate with cross-functional teams across the product lifecycleAct as a senior point of contact and support and guide team members in day-to-day activitiesLiaise with regulatory authorities and internal stakeholdersDrive continuous improvement and process optimizationAuthorize regulatory documents and support audits and reportingWhat You Bring5+ years’ experience in Regulatory Affairs (medical devices)Experience with regulatory submissions and project managementMaster’s degree in Engineering, Science, or similarStrong knowledge of global regulationsExperience supporting, guiding, or mentoring colleagues in a team settingExcellent communication skills in EnglishProactive, structured, and detail-orientedWhat Makes You SuccessfulYou are committed to quality and integrityYou proactively drive change and improvementYou bring creative solutions to complex challengesYou thrive in a dynamic, international environmentWe 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!
You will be part of our international innovative team and given the opportunity to learn and develop.
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)
Hiring processWe are looking forward to hearing from you! Apply by submitting your application and resumé in English, via the “Apply” button.
Please note that we do not accept applications by e-mail.
We are an equal opportunity employerWe 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.
We are a MedTech company that provides software and hardware to hospitals and clinics all over the world. xbelvxb
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.
SummaryLocation: VeenendaalType: Full time
Sr Regulatory Engineer in Veenendaal werkgever: Elekta
Elekta is een werkgever die zich inzet voor een hoger doel: hoop bieden aan iedereen die met kanker te maken heeft. Met een sterke focus op innovatie en samenwerking, biedt Elekta een stimulerende werkomgeving in Veenendaal, waar medewerkers de kans krijgen om te groeien en bij te dragen aan baanbrekende oplossingen in de gezondheidszorg. De uitstekende secundaire arbeidsvoorwaarden, waaronder 27 vakantiedagen, een globaal bonusplan en mogelijkheden voor hybride werken, maken het een aantrekkelijke plek voor professionals die een betekenisvolle impact willen maken.
