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Senior Manager – Post Market Intelligence, Monitoring & Innovation
Convatec. Lead the global operating model for post-market monitoring, trending, signal detection and escalation, including governance, methodologies, thresholds and continuous improvement .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Post-Market Surveillance, Complaint Management, and Regulatory Affairs within the medical device or pharmaceutical industry, with a strong focus on data analytics, risk management, and continuous improvement. Proven ability to lead cross-functional teams and drive automation and transformation initiatives while ensuring compliance with regulatory standards.
Highest-signal resume keywords
Post-Market SurveillanceComplaint AnalyticsRegulatory AffairsData AnalysisProcess Improvement
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Signal DetectionProduct MonitoringTrending ProcessesCAPAStatistical AnalysisRisk ManagementDigital Solutions ImplementationDashboard DevelopmentAnalytics PlatformsISO 13485 Compliance
Soft Skills
LeadershipCoachingCommunicationJudgementTrust Building
Tools & Technologies
AI-Enabled SolutionsData PipelinesMonitoring ToolsReporting ToolsQuality Systems
Certifications & Qualifications
ASQ CQEASQ CQMRACPMPLean Six Sigma Green Belt
Industry Keywords
Medical DevicePharmaceuticalEU MDRISO 14971FDA Quality System
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Lead the global operating model for post-market monitoring, trending, signal detection and escalation, including governance, methodologies, thresholds and continuous improvement
- Translate complaint, vigilance, product-performance and customer-feedback data into evidence-based, risk-based insights for leadership and Quality governance forums
- Oversee post-market surveillance plans and reports, PSUR inputs and outputs, product-monitoring reviews, ad hoc surveillance assessments and related deliverables
- Lead consistent, fact-based communications on product trends, complaint performance and investigation outcomes for customers and internal stakeholders
- Act as business leader for post-market tools and digital capabilities, including analytics platforms, dashboards, data pipelines and AI-enabled solutions
- Define and prioritise the post-market technology roadmap with IT, Data, Digital, Quality Systems and business stakeholders
- Drive automation and continuous improvement across post-market data preparation, monitoring, reporting and communication
- Lead cross-functional transformation and remediation initiatives arising from audits, inspections, CAPAs, nonconformances, signal investigations and performance monitoring
- Establish and monitor KPIs covering data quality, monitoring effectiveness, trend timeliness, signal management, action closure, tool performance and improvement delivery
- Represent the function during internal and external audits, notified body assessments, regulatory inspections and agency interactions
- Lead, coach and develop a global multidisciplinary team
- Partner across Complaint Handling, Vigilance, Medical and Clinical, Regulatory, Risk Management, R&D, Operations, Commercial, Customer Service, Legal and Quality Engineering
Requirements
What you’ll need- Minimum of 10 years’ experience in Quality, Post-Market Surveillance, Complaint Management, Vigilance, Regulatory Affairs or a related function within the medical device or pharmaceutical industry
- At least 5 years’ people leadership experience, with evidence of coaching, developing and guiding teams through change
- Strong hands-on knowledge of post-market surveillance, complaint analytics, product monitoring, trending, signal detection and escalation processes
- Working knowledge of ISO 13485 requirements, particularly complaint handling, data analysis, CAPA, risk management and post-market activities
- Working knowledge of EU MDR requirements relating to post-market surveillance, PMCF, PSURs, vigilance, trend reporting and post-market data evaluation
- Understanding of statistical and risk-based approaches used for complaint trending, signal detection and product monitoring
- Experience implementing analytics, dashboards, reporting, digital or AI-enabled solutions within a regulated environment
- Experience leading process improvement, remediation, compliance transformation or global cross-functional initiatives
- Experience supporting regulatory inspections, notified body assessments, customer audits or agency interactions
- Ability to communicate complex product-performance trends and investigation outcomes clearly to customers, senior leaders and cross-functional partners
- Strong judgement, constructive challenge and confidence to provide clear feedback while building trust across a global organisation
- Bachelor’s degree in Engineering, Life Sciences, Statistics, Data Analytics, Quality, Regulatory Affairs, Business or a related STEM field
- Master’s degree, MBA or equivalent advanced qualification would be advantageous
- Professional certifications such as ASQ CQE/CQM, RAC, PMP, Lean Six Sigma Green Belt or Black Belt, or an equivalent qualification, would be beneficial
- Knowledge of ISO 14971, FDA Quality System and post-market requirements, or other international vigilance and post-market frameworks, would be an advantage
- UK-based work eligibility/location
- Ability to travel domestically and internationally up to 10–15%
Benefits
Comp & perks- Flexible working hours in line with Convatec’s flexible working policy and agreement with the manager
- Remote work arrangement
- Global leadership and professional development opportunities through leading, coaching and developing a multidisciplinary team