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

Hilobyaktiia · FranceRemotosenior

En corto

▸Gestiona el sistema global de vigilancia post-comercialización de un dispositivo médico de presión arterial sin manguito.
▸Supervisa la recepción, análisis y reporte de quejas y eventos adversos ante reguladores (EU, EE. UU.) con plazos rigurosos y calidad clínica.
▸Es el líder técnico y de procesos que convierte datos de post-mercado en mejoras reales del producto y seguridad del paciente.

Fluent English required for global collaboration and regulatory communications.

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¿Qué piden?

✓7+ años en vigilancia post-comercialización, manejo de quejas o afines en dispositivos médicos.
✓Experiencia comprobada en evaluaciones de reportabilidad y presentaciones a reguladores (FDA MDR, UE MDR).
✓Conocimiento en ISO 13485, ISO 14971, y gestión de riesgos basada en datos.
✓Capacidad para liderar procesos complejos con múltiples áreas (QA, Ingeniería, Producto, etc.).
✓Habilidad para analizar datos de quejas y convertirlos en acciones correctivas (CAPA, actualizaciones de producto).
✓Comunicación efectiva con equipos multidisciplinarios y autoridades reguladoras.

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FDA MDREU MDR vigiliance/PMSISO 13485ISO 14971CAPArisk managementPSURPost-Market Surveillancecomplaint handlingadverse-event reporting

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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-based recommendations Strong communicator, comfortable influencing cross-functional teams, leadership, and regulators Hands-on, independent leadership style; able to scale processes as we grow Nice to have: experience with additional international markets or digital complaint-management systems What success looks like Scalable processes for complaint intake, investigation, and resolution — with clear escalation pathways to ensure adverse events and reportable incidents are identified, assessed, and reported within regulatory timeline Customer Support consistently identifies, documents, and escalates complaints and potential safety events, thanks to close partnership and training KPIs and dashboards give clear visibility into complaint timeliness, resolution, regulatory reporting, and emerging trends Post-market insights translate into action — product improvements, CAPAs, risk-management updates, and a better customer experience Benefits What Makes You A Great Fit At Hilo by Aktiia, our values guide everything we do: Move the Needle — You focus on what drives real impact. You let data and

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