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-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 clarity guide your decisions, and you take accountability for results. You're a difference maker — you drive ideas to commercial success from start to end Move Fast, Learn, Refine — You work with urgency and purpose, balancing speed with quality. You treat feedback as a chance to learn, and you're deep in customer and partner feedback — translating it to action quickly Team First — You collaborate effectively across teams and build trust through clarity and respect. You're comfortable bridging local execution with a global team, and you communicate openly across time zones Why Join Us? Hilo by Aktiia is becoming one of the most important med-tech companies, and you can be part of this exciting story Work on a mission that matters: transforming cardiovascular health at global scale Be part of a high-impact, fast-growing, and venture-backed scale-up company Collaborate with a diverse, passionate, and talented team Competitive compensation and equity program, and other benefits (depending on location) Ready to Move the Needle? If you are passionate about making a meaningful impact in people's lives and excel in an environment where individuals take ownership and are committed to delivering results, we are happy to receive your application. Find more English Speaking Jobs in Germany on Arbeitnow