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

This is a fully remote position, open to applicants in Switzerland, +5 more countries.

📋 Description

• Design, develop, and oversee the global post-market surveillance system.

• Manage complaint resolution, adverse event/vigilance reporting, escalation processes, and governance.

• Address complex or high-risk post-market situations.

• Own the complaint-to-report pipeline, which includes reportability evaluations and adverse event/vigilance submissions across the US, EU, and other regions.

• Establish KPIs, dashboards, and trending methodologies to detect safety, quality, and customer experience indicators.

• Convert findings into actionable steps through CAPA, risk management, product/software corrections, and labeling modifications.

• Lead cross-functional implementations by developing plans, setting priorities, managing dependencies, and overseeing risk management.

• Present post-market performance metrics and recommendations to senior management.

• Assist with PMS reports, PSURs, and management evaluations.

• Serve as a subject matter expert during audits and inspections.

• Advise internal teams and external partners on post-market operations.

• Collaborate with Customer Support, Quality Assurance, Regulatory, Engineering, Clinical, and Product teams.

⛳️ Requirements

• 7+ years of experience in medical device post-market surveillance, complaint management, quality assurance, or regulatory affairs, including leadership in process implementation.

• A minimum of a bachelor's degree.

• Practical experience in complaint investigations, reportability evaluations, and regulatory submissions.

• Familiarity with FDA MDR, EU MDR vigilance/PMS, ISO 13485, and ISO 14971.

• Experience in analyzing post-market data.

• Skills in program management encompassing workstreams, stakeholders, and dependencies.

• An analytical mindset for translating complaint data into risk-based recommendations.

• Excellent communication abilities and the capacity to influence cross-functional teams, leadership, and regulatory bodies.

• A hands-on, independent approach to leadership.

• Capability to scale processes in line with company growth.

• Preferred: experience with additional international markets or digital complaint management systems.

🏝️ Benefits

• Competitive salary.

• Equity participation program.

• Additional benefits based on location.

• Opportunity to contribute to a mission that transforms cardiovascular health on a global scale.

• A high-impact, rapidly growing, venture-backed scale-up environment.

• Collaboration with a diverse, passionate, and talented team.