Senior Post-Market Surveillance Manager – m/f/d

🔥 3 minutes ago

🌐 Switzerland, Germany, +4 more countries – Remote

🇨🇭 Switzerland – Remote 🇩🇪 Germany – Remote 🇫🇷 France – Remote 🇪🇸 Spain – Remote 🇬🇧 United Kingdom – Remote 🇵🇹 Portugal – Remote

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Hilo by Aktiia

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🏥 Healthcare

🤖 Artificial Intelligence

Healthcare • Artificial Intelligence

Hilo by Aktiia is a healthcare company focused on transforming blood pressure monitoring through innovative, AI-powered technology. Established in 2018, Hilo offers cuffless solutions that provide continuous and accessible insights for both individuals and healthcare professionals. With a foundation model trained on extensive datasets, involving billions of optical signals, the company is redefining hypertension management and contributing to the field through numerous peer-reviewed publications and patents. Headquartered in Switzerland, Hilo is on a mission to improve global health outcomes related to blood pressure.

📋 Description

• Design, build, and run the global post-market surveillance system • Manage complaint handling, adverse-event/vigilance reporting, escalation, and governance • Handle complex or high-risk post-market cases • Own the complaint-to-report pipeline, including reportability assessments and adverse-event/vigilance submissions across US, EU, and other markets • Build KPIs, dashboards, and trending methods to identify safety, quality, and customer-experience signals • Turn findings into action through CAPA, risk management, product/software fixes, and labeling updates • Lead cross-functional rollout through implementation plans, priorities, dependencies, and risk management • Present post-market performance and recommendations to leadership • Support PMS reports, PSURs, and management reviews • Act as subject matter expert during audits and inspections • Guide internal teams and external partners on post-market activities • Partner with Customer Support, QA, Regulatory, Engineering, Clinical, and Product

🎯 Requirements

• 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 • Experience with FDA MDR, EU MDR vigilance/PMS, ISO 13485, and ISO 14971 • Experience with post-market data analysis • Program management skills covering workstreams, stakeholders, and dependencies • Analytical mindset for turning complaint data into risk-based recommendations • Strong communication skills and ability to influence cross-functional teams, leadership, and regulators • Hands-on, independent leadership style • Ability to scale processes as the company grows • Nice to have: experience with additional international markets or digital complaint-management systems

🏖️ Benefits

• Competitive compensation • Equity program • Other benefits depending on location • Opportunity to work on a mission transforming cardiovascular health at global scale • High-impact, fast-growing, venture-backed scale-up environment • Collaboration with a diverse, passionate, and talented team