Post-Market Surveillance Manager

Core Responsibilities

• Design, build, and run our global post-market surveillance system, including complaint handling, adverse-event/vigilance reporting, escalation, and governance, with hands-on involvement in complex or high-risk cases.

• Own the complaint-to-report pipeline, ensuring reportability assessments and timely, accurate adverse-event/vigilance submissions across markets (US, EU, and others).

• Develop KPIs, dashboards, and trending methods to surface safety, quality, and customer-experience signals, translating findings into action via CAPA (Corrective and Preventive Actions), risk management, product/software fixes, and labeling updates.

• Lead cross-functional rollout, including implementation plans, priorities, dependencies, and risk management to build sustainable post-market processes and infrastructure.

• Present post-market performance and recommendations to leadership, and support PMS reports, PSURs (Periodic Safety Update Reports), and management reviews.

• Act as a Subject Matter Expert (SME) during audits and inspections, guiding 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 — managing workstreams, stakeholders, dependencies — with 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 the company grows.
• 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 timelines.
• Customer Support consistently identifies, documents, and escalates complaints and potential safety events, thanks to close partnership and training.
• KPIs and dashboards provide clear visibility into complaint timeliness, resolution, regulatory reporting, and emerging trends.
• Post-market insights translate into actionable improvements, including product enhancements, CAPAs, risk-management updates, and a better customer experience.

Company Values

Move the Needle — Focus on real impact, driven by data and accountability.

Move Fast, Learn, Refine — Work with urgency, treat feedback as learning opportunities, and translate customer insights into action quickly.

Team First — Collaborate effectively across teams, build trust, and communicate openly across time zones.

Why Join Us?

• Join a high-impact, fast-growing, venture-backed scale-up in the med-tech industry.
• Work on a mission to transform cardiovascular health at a global scale.
• Collaborate with a diverse, passionate, and talented team.
• Competitive compensation, equity program, and other benefits (location-dependent).