Senior Manager - Post Market Intelligence, Monitoring & Innovation
ConvaTec Inc, Shotton, Sir y Fflint - Flintshire
Senior Manager - Post Market Intelligence, Monitoring & Innovation
Salary not available. View on company website.
ConvaTec Inc, Shotton, Sir y Fflint - Flintshire
- Full time
- Permanent
- Remote working
Posted 1 week ago, 24 Oct | Get your application in now before you miss out!
Closing date: Closing date not specified
Job ref: b6676d3d08e443a19e38f0aad4a29e7f
Location ref: Shotton, Sir y Fflint - Flintshire
Full Job Description
At Convatec, we're pioneering trusted medical solutions to improve the lives we touch. We're looking for a Senior Manager, Post Market Intelligence, Monitoring & Innovation to lead a global team that turns post-market data into timely, reliable and actionable intelligence. This is a high-impact leadership role at the intersection of post-market surveillance, complaint analytics, digital enablement and process transformation. You'll shape how emerging signals and product-performance concerns are identified, evaluated, communicated and acted upon, while helping advance the use of analytics, automation and AI-enabled tools in a highly regulated environment. You'll also play an important role in developing the capability of an established, multidisciplinary team, bringing external knowledge, strong technical judgement and a practical leadership style that raises standards across the function. Your key duties and responsibilities:
- 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 clear, evidence-based and 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 the development of 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, ensuring appropriate governance, traceability, human oversight and inspection-ready documentation.
- Drive automation and continuous improvement across post-market data preparation, monitoring, reporting and communication while maintaining reliable, controlled and reproducible processes.
- 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, creating clear expectations, strengthening technical capability and providing constructive feedback that supports growth and accountability.
- Partner across Complaint Handling, Vigilance, Medical and Clinical, Regulatory, Risk Management, R&D, Operations, Commercial, Customer Service, Legal and Quality Engineering., The position may require domestic and international travel of up to 10-15% to support business reviews, customer engagements, audits, inspections, leadership meetings and site activities. Working Conditions:
- This is a UK-based remote role.Occasional onsite presence is required at Deeside and/or London.
- Flexible working hours apply in line with Convatec's flexible working policy and agreement with the manager.
A 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.
- The ability to communicate complex product-performance trends and investigation outcomes clearly to customers, senior leaders and cross-functional partners.
- Strong judgement, constructive challenge and the confidence to provide clear feedback while building trust across a global organisation. Qualifications/Education:
- Bachelor's degree in Engineering, Life Sciences, Statistics, Data Analytics, Quality, Regulatory Affairs, Business or a related STEM field.
- A 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., If you're an experienced post-market leader who can combine technical depth, people leadership and a transformation mindset, we'd love to hear from you. Apply today and help us strengthen the intelligence, tools and decisions that support product quality, customer confidence and patient safety.