Senior Post-Market Surveillance Manager
New
H
Hilo by AktiiaMed-tech
Switzerland. Germany. France. Spain. United Kingdom. PortugalFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 7+ years in medical-device post-market surveillance, complaint handling, quality, or regulatory affairs
- Required Skills
- Data AnalysisQuality Assurance
Requirements
- 7+ years of experience in medical-device post-market surveillance, complaint handling, quality, or regulatory affairs.
- Demonstrated experience leading process implementations.
- Bachelor's degree or higher.
- Hands-on experience with complaint investigations, reportability assessments, and regulatory submissions.
- In-depth knowledge of FDA MDR, EU MDR vigilance/PMS, ISO 13485, and ISO 14971.
- Experience with post-market data analysis.
- Strong program management skills including experience managing workstreams, stakeholders, and dependencies.
- Analytical mindset for turning complaint data into risk-based recommendations.
- Strong communication skills with the ability to influence cross-functional teams and leadership.
Responsibilities
- Design, build, and run the global post-market surveillance system covering complaint handling, adverse-event reporting, escalation, and governance.
- Manage the complaint-to-report pipeline, including reportability assessments and timely submissions across global markets.
- Develop KPIs, dashboards, and trending methods to surface safety, quality, and customer-experience signals.
- Lead cross-functional rollouts of post-market processes and infrastructure, managing priorities and dependencies.
- Present performance recommendations to leadership and support PSURs and management reviews.
- Act as a subject matter expert during audits and inspections, guiding internal teams and external partners.
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