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Hilo by Aktiia is a venture-backed medical-device company ($96M raised) building cuffless, continuous blood pressure monitors—the world's only clinically validated, CE-marked Class IIa device for daily use. Now available in 12 countries and recently launched in the US, the company is remote-first, headquartered in Neuchâtel, Switzerland, and focused on transforming cardiovascular health globally.
As Senior Post-Market Surveillance Manager, you will design, build, and operate the company's global post-market surveillance system from the ground up. This is a hands-on leadership role spanning complaint handling, adverse-event and vigilance reporting, data trending, and governance across Customer Support, QA, Regulatory, Engineering, Clinical, and Product teams.
Key responsibilities include: designing and running the complaint-to-report pipeline with reportability assessments and timely submissions across US, EU, and other markets; building KPIs, dashboards, and trending methods to surface safety, quality, and customer-experience signals; translating post-market findings into action via CAPA, risk management, product/software fixes, and labeling updates; leading cross-functional rollout with implementation plans and risk management; presenting post-market performance to leadership and supporting PMS reports, PSURs, and management reviews; and serving as subject-matter expert during audits and inspections.
You will need 7+ years in medical-device post-market surveillance, complaint handling, quality, or regulatory affairs, including process-implementation leadership. Required expertise: complaint investigations, reportability assessments, regulatory submissions (FDA MDR, EU MDR vigilance/PMS, ISO 13485, ISO 14971), and post-market data analysis. Strong program-management skills, analytical mindset, and cross-functional influence are essential. A bachelor's degree is required; experience with international markets or digital complaint-management systems is a plus.
Success means building scalable complaint intake, investigation, and resolution processes with clear escalation pathways; enabling Customer Support to consistently identify and escalate safety events; delivering dashboards with visibility into complaint timeliness, resolution, and trends; and translating post-market insights into product improvements and better customer experience.
