Compliance Officer (Remote)
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Overview
Job Description
Deploying autonomous robots into hospitals means operating in one of the most regulated environments in the world. As our compliance officer, you'll own the regulatory, safety, and security compliance framework that lets STAT, TOTE, LIFT, and LIFT+ operate legally, safely, and with the full confidence of our hospital partners. Reporting closely to the CTO, you'll work across hardware compliance, functional safety, and information security — building the compliance infrastructure our fleet depends on as we scale. This is a contract role with scope to grow.
What you'll do
- Lead regulatory compliance across the fleet — FDA, CE marking, and relevant ISO standards for autonomous systems in healthcare
- Develop and maintain the functional safety framework — risk assessments, hazard analyses, and safety case documentation
- Own our SOC 2 programme — maintaining documentation, gathering and organising evidence, and keeping us audit-ready at all times
- Interpret and apply hospital and clinical environment standards to our deployment model
- Build and maintain audit-ready documentation — technical files, compliance records, and regulatory submissions
- Work closely with the CTO and engineering team to ensure compliance is embedded in product development from day one
- Monitor the evolving regulatory landscape for autonomous systems in healthcare
What we're looking for
- 3–5 years of regulatory compliance experience with medical devices or complex hardware in regulated industries
- Practical knowledge of FDA pathways, CE marking processes, and relevant ISO standards (ISO 13485, ISO 14971, or similar)
- Hands-on experience managing a SOC 2 programme — including evidence collection and readiness for Type I or Type II audits
- Working knowledge of functional safety standards — IEC 62443, ISO 26262, or equivalent
- Familiarity with hospital compliance requirements — infection control standards, IEC 60601 electrical safety
- Strong technical writing skills — able to produce clear, precise documentation that holds up under audit
- Self-directed and comfortable working remotely and closely with senior leadership
Nice to have
- Experience with ETL, CE, or UL product certification processes
- Experience with autonomous mobile robots (AMRs) or robotics compliance
- Knowledge of UL 3100 or ANSI/RIA R15.08 robot safety standards
- Experience supporting hospital procurement or credentialing processes
- Background in quality management systems (QMS)
- CUSA, CRC, or equivalent compliance certification
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