{"id":508949,"url":"https://alion.io/job/scarlet-lead-auditor-contractor","title":"Lead Auditor - Contractor","company":{"id":3908732,"name":"Scarlet","domain":"scarlet.cc","url":"https://alion.io/company/scarlet-cc","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Ashby","truth_index":null},"role":"Finance","role_family":"Finance","seniority":"lead","employment_type":"contractor","work_mode":"remote","remote_scope":"stated_regions","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":[],"countries":[],"hiring_countries":["US","DE","FR","GB","AT","BE","BG","HR","CY","CZ","DK","FI","HU","IE","IT","NL","NO","PL","RO","ES","SE","CH","EE","GR","IS","LV","LI","LT","LU","MT","PT","SK","SI"],"hiring_countries_total":33,"salary":null,"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"AI Agents","optional":false}],"status":"live","first_seen_at":"2026-01-08T18:37:18Z","employer_posted_date":"2026-01-08","last_verified_at":"2026-10-20T06:09:06Z","board_verified":true,"closed_at":null,"days_open":284,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":284},"description":"We pull medical technology from the future to solve human health.\nScarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigorous certification can keep pace with product development at the world’s most ambitious technology companies, without lowering the safety bar.\nOur customers have cut a year or more from their certification timelines for new AI-enabled medical devices and shortened product-update cycles from months to weeks. You’ll join a team building the infrastructure that makes these outcomes repeatable at scale.\nAbout the role\nAs a Lead Auditor - Contractor at Scarlet, you will independently deliver efficient, high-quality QMS audits that help innovative medical device companies meet the highest regulatory standards.\nWe’re expanding our auditor pool, and we're looking for part-time/contractor lead auditors who can independently deliver audits in line with Scarlet’s standards, approach and culture.\nThis role is suited for auditors who fulfil the relevant criteria to be authorised as a Lead Auditor in a Certification or Notified Body under ISO 13485, EU MDR and UK MDR. You will work flexibly, supporting audit delivery as part of Scarlet’s notified body activities. This is a fully remote role, with flexible scheduling, subject to audit demand and availability.\nResponsibilities\nConduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, EU MDR, and UK MDR.\n\nProvide clear, structured audit documentation and evidence-based conclusions.\n\nContribute to consistent, high-quality audit experiences aligned with Scarlet’s audit methodology and values.\n\nRequired qualifications\nA bachelor’s degree in either:\nsoftware engineering\n\ncomputer science\n\nphysics or biophysics\n\nbiology or microbiology\n\nchemistry or biochemistry\n\nelectrical, electronic, mechanical engineering or bioengineering\n\nhuman physiology\n\nmedicine\n\npharmacy\n\nMinimum 4 years of experience in the medical device industry\n\nMinimum 2 years of experience auditing or managing QMSs under:\nISO 13485\n\nEU MDR and/or UK MDR\n\nPrior work with notified bodies or accreditation bodies as a Lead Auditor\n\nWorking knowledge of relevant standards, such as:\nISO 14971\n\nIEC 62304\n\nIEC 82304\n\nCybersecurity\n\nEvidence of confidently interpreting and applying regulatory requirements.\n\nEvidence of delivering consistent, high-quality audits.\n\nAbility to explain findings and requirements clearly and constructively.\n\nAbility to deliver audits independently with minimal oversight.\n\nWillingness to adopt Scarlet’s values, audit methods and tooling.\n\nPreferred qualifications\nPractical experience working with software.\n\nExperience with software medical devices (SaMD).\n\nInterview process\nIntroductory call with Emily (30 min)\n\nAuditor competence & regulatory interviews (2x30-45 min)\n\nReferences\n\nOffer & 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