Elixi
Compliance Manager (Health and medical regulation)
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About The Company
Elixi is an AI-driven HealthTech startup with a mission to democratize long-term health by transforming scattered data into insights and recommendations people can trust and act on. We’re led by a successful tech entrepreneur who has built a global decacorn ($10B+) before — and has the ambition and resources to do it again.
This is a chance to join early and directly influence what we build, how we build it, and the culture we create along the way. We operate as a small, relentless team with strong ownership and high standards — if you’re driven to achieve greatness and grow alongside ambitious peers, you’ll feel at home.
About The Role
We are looking for a Compliance Manager to drive our regulatory and certification efforts across global markets. In this role, you will monitor evolving health, medical device, data privacy, and AI regulations, and translate them into clear, actionable guidance for our product and operations teams.
What You'll Be Doing
- Analyze and interpret applicable regulatory frameworks across markets (e.g. US, EU, UK, RoW) related to health software, medical devices, data protection and AI
- Manage the company’s certification roadmap, coordinating cross-functional efforts to meet required standards and timelines
- Translate complex regulatory requirements into clear, product-oriented internal documentation, frameworks, and checklists for ongoing compliance tracking
- Act as day-to-day advisor to product and engineering teams on regulatory questions during development of new features or infrastructure changes
- Conduct internal compliance audits and periodic reviews to assess adherence and identify areas for improvement
- Prepare documentation and deliver workshops for product and engineering teams to ensure regulatory awareness and ongoing alignment
- Monitor upcoming changes in regulations, evaluate their impact on the product, and drive internal adaptation plans
- Engage and manage external legal and regulatory advisors where needed, ensuring their input is challenged and implemented only where practical and risk-effective
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What You'll Need
- At least 3 years of experience in regulatory compliance, preferably within medical devices, ideally within digital health, MedTech, health SaaS, or a relevant advisory/regulatory body (e.g. notified body, consultancy)ячы
- Hands-on experience with regulators
- Deep familiarity with key regulatory frameworks such as MDR, FDA regulations on Medical Devices, ISO 13485, GDPR, and ideally HIPAA, EHDS
- Proven ability to translate complex regulations into clear, actionable internal documentation for product, engineering, and operations teams
- Experience building or managing internal compliance tracking systems, certification roadmaps, and audit preparation processes
- Strong project ownership and ability to lead end-to-end compliance initiatives, including during product development and market entry
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Nice to have
- Completed (as a lead or a key team member) at least 3 regulatory certification procedures (preferably in EU, US, or UK and in medical devices) from start to finish
- Experience with regulatory compliance for AI-based health software, such as e.g. EU AI Act
- Experience with IP law
- Background in biomedical science, health policy, law, public health, or similar field (academic or professional)
- Familiarity with privacy-by-design, compliance automation, and internal audit tooling
By submitting this application, I agree that my personal data will be collected, processed, and retained by the company solely for the purposes of managing and assessing my candidacy.
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