Senior Post-Market Surveillance Manager (m/f/d)

Company & Role Overview About Hilo by Aktiia High blood pressure is the world's most common disease, causing 18M deaths each year. At Hilo by Aktiia, we're building a world where no lives are lost to its effects — with technology that helps people take control of their health. We're a venture-backed scale-up with $96M raised from investors in Europe and the US. Rooted in 18 years of research at the Swiss Center for Electronics and Microtechnology (CSEM), our device is the world's only medically accurate, cuffless, continuous blood pressure monitor for daily use — clinically validated and CE Marked as a Class IIa medical device, now available in 12 countries. In July, we launched in the US. We're a remote-first company headquartered in Neuchâtel, Switzerland, united by our passion for impact and innovation. Role overview As Post-Market Surveillance Manager, you'll build and run our global post-market surveillance system — from complaint handling and adverse-event reporting to data trending and governance — and lead its rollout across Customer Support, QA, Regulatory, Engineering, Clinical, and Product. This is a hands-on role: you'll turn post-market insights into action that improves product quality, patient safety, and the customer experience, drawing on strong judgment, disciplined execution, and the ability to influence stakeholders globally. Requirements Core responsibilities Design, build, and run our global post-market surveillance system — complaint handling, adverse-event/vigilance reporting, escalation, and governance — staying hands-on for complex or high-risk cases Own the complaint-to-report pipeline: reportability assessments and timely, accurate adverse-event/vigilance submissions across markets (US, EU, and others) Build the KPIs, dashboards, and trending methods that surface safety, quality, and customer-experience signals — and turn findings into action via CAPA, risk management, product/software fixes, and labeling updates Lead the cross-functional rollout — implementation plans, priorities, dependencies, and risk — to build sustainable post-market processes and infrastructure Present post-market performance and recommendations to leadership, and support PMS reports, PSURs, and management reviews Act as SME during audits and inspections, and guide internal teams and external partners on post-market activities Background & Experience 7+ years in medical-device post-market surveillance, complaint handling, quality, or regulatory affairs, including leading process implementations At least a bachelor's degree Hands-on experience with complaint investigations, reportability assessments, and regulatory submissions (FDA MDR, EU MDR vigilance/PMS, ISO 13485, ISO 14971), plus post-market data analysis Program management skills — workstreams, stakeholders, dependencies — plus an analytical mindset for turning complaint data into risk-base