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

Hilobyaktiia; France; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Equity program

Competitive compensation

Remote-first culture

Global exposure

Zusammenfassung

Hilo by Aktiia is seeking a Post-Market Surveillance Manager to build and run a global PMS system, driving complaint handling, adverse-event reporting, and governance across multiple markets. You will lead cross-functional initiatives with Customer Support, QA, Regulatory, Engineering, Clinical, and Product to translate insights into actions that improve product quality and patient safety.

You will own the end-to-end PMS process, including data analysis, CAPA, risk management, and labeling

Qualifikationen

• 7+ years in medical-device post-market surveillance or regulatory affairs.
• Hands-on experience with complaint investigations and regulatory submissions.
• Strong data-driven mindset and risk-based thinking.
• Proven ability to lead cross-functional programs.

Aufgaben

• Design, build, and run global PMS system including complaint handling and vigilance reporting.
• Own the complaint-to-report pipeline across markets.
• Develop KPIs, dashboards, and trend analyses to drive improvements.
• Lead cross-functional rollout and governance of PMS processes.
• Present performance and support audits and management reviews.
• Act as SME during audits and guide teams and partners.

Kenntnisse

Post-market surveillance

Regulatory affairs

Quality management

Program management

Cross-functional leadership

Regulatory submissions

Data analysis

Auditing

Stakeholder influence

Ausbildung

Bachelor's degree

Jobbeschreibung

Company & Role Overview

High blood pressure is the world's most common disease, causing 18M deaths each year.At Hilo byAktiia,we'rebuilding a world where no lives are lost to its effects — with technology that helps people take control of their health.

We'rea 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'rearemote-firstcompany headquartered in Neuchâtel, Switzerland, united by our passion for impact and innovation.

About Hilo by Aktiia

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 byAktiia, 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?