{"id":1289176,"url":"https://alion.io/job/elekta-senior-regulatory-affairs-engineer","title":"Senior Regulatory Affairs Engineer","company":{"id":1801963,"name":"Elekta","domain":"elekta.com","url":"https://alion.io/company/elekta-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":88,"open_postings":15,"ghost_share":0,"stale_share":0.467,"repost_share":0,"time_to_fill_p50_days":56,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Veenendaal, Netherlands"],"countries":["NL"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":70000,"max_usd":144000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":543},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-06T00:00:00Z","employer_posted_date":"2026-08-06","last_verified_at":"2026-11-03T14:24:29Z","board_verified":true,"closed_at":null,"days_open":89,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":89},"description":"Are you a current Elekta employee?\nPlease click here to apply through our internal career site Find Jobs - Elekta.\nWe don’t just build technology. We build hope for everyone dealing with Cancer.\nElekta 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. Each year more than 2 million patients are treated using Elekta solutions across over 130 countries. Elekta is headquartered in Stockholm, Sweden, with over 4,000 employees and offices in more than 40 countries. The company is listed on Nasdaq Stockholm. For more information, visit elekta.com.\nWe don’t just build technology. We build hope for everyone dealing with Cancer.\nAt 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.\nThis role is based in Veenendaal, Netherlands.\nSenior Regulatory Affairs Engineer (Team Lead)\nWhat you’ll do at Elekta\nAs 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.\nYou’ll work closely with cross-functional teams to ensure products meet international regulatory requirements and are successfully introduced and maintained in global markets.\nResponsibilities\nEnsure and maintain regulatory approvals and compliance across targeted markets\nPrepare and submit regulatory documentation to governing authorities\nTranslate regulations into clear business requirements\nCollaborate with cross-functional teams across the product lifecycle\nAct as a senior point of contact and support and guide team members in day-to-day activities\nLiaise with regulatory authorities and internal stakeholders\nDrive continuous improvement and process optimization\nAuthorize regulatory documents and support audits and reporting\nWhat You Bring\n5+ years’ experience in Regulatory Affairs (medical devices)\nExperience with regulatory submissions and project management\nMaster’s degree in Engineering, Science, or similar\nStrong knowledge of global regulations\nExperience supporting, guiding, or mentoring colleagues in a team setting\nExcellent communication skills in English\nProactive, structured, and detail-oriented\nWhat Makes You Successful\nYou are committed to quality and integrity\nYou proactively drive change and improvement\nYou bring creative solutions to complex challenges\nYou thrive in a dynamic, international environment\nWe 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!\nWhy should you join Elekta?\nIn 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.\nOverview of some of our benefits for Veenendaal are as below.\n27 paid vacation days per year plus 13 ATV days \nGlobal bonus plan or Profit scheme \nTravel allowance \nGood pension fund Metalektro, 50/50 payment \nInsurance discounts \nActive staff association \nTax benefits for fitness centres and bicycle purchases \nHybrid work option (you are required to work on location at least 4 days/week) \nHiring process\nWe 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.\nYour Elekta contact\nFor questions, please contact the responsible hiring manager, Matilda Forsberg, .\nWe are an equal opportunity employer\nWe 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.\nAbout Elekta\nHere 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.\nWe have a responsibility toward our partners and customers to deliver solutions in a secure and sustainable way. 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