Surveillance Manager

Role – Post Market Surveillance Manager / Lead

The PMS Lead/Manager is responsible for leading the organization's global Post Market Surveillance (PMS) and Vigilance programs, ensuring continued safety, performance, and regulatory compliance of marketed medical devices. The role oversees PMS strategy, complaint management, adverse event reporting, signal detection, trend analysis, risk management integration, and regulatory reporting activities while maintaining compliance with EU MDR, FDA, ISO 13485, ISO 14971, and other applicable global regulations.

The individual will provide leadership to cross-functional teams, drive continuous improvement initiatives, support regulatory inspections and audits, and act as a key subject matter expert for post-market product safety and performance.

Key Responsibilities:

PMS Strategy & Leadership

• Lead and manage the global Post Market Surveillance program across all product portfolios.
• Develop and implement PMS strategies, procedures, and governance frameworks aligned with regulatory requirements and business objectives.
• Establish PMS performance metrics, dashboards, and KPIs.
• Provide leadership, mentoring, and guidance to PMS and Vigilance team members.
• Drive a proactive culture of patient safety, product quality, and regulatory compliance.

Complaint Handling & Vigilance Management

• Oversee global complaint handling activities and ensure timely investigation and closure.
• Review and approve reportability assessments for adverse events and field safety issues.
• Ensure timely submission of regulatory reports to global health authorities.
• Lead decision-making related to field corrective actions, recalls, and safety communications.

Regulatory Compliance & Risk Management

• Ensure compliance with:
• EU MDR 2017/745
• FDA Medical Device Reporting (MDR)
• ISO 13485
• ISO 14971
• Health Canada, UK MDR, TGA, and other global regulations
• Partner with Regulatory Affairs and Risk Management teams to maintain risk management files throughout the product lifecycle.
• Ensure PMS findings are appropriately incorporated into risk-benefit evaluations.

Data Analytics

• Lead trend analysis activities using complaint, service, literature, and clinical data.
• Evaluate emerging risks and recommend mitigation strategies.
• Present PMS trends and product safety insights to senior leadership.
• Drive utilization of data analytics tools and methodologies to improve surveillance effectiveness.

PMCF, PSUR & Regulatory Reporting

• Closely work with Clinical Affairs , Oversee preparation and approval of:
• PMS Plans
• PMS Reports
• Periodic Safety Update Reports (PSURs)
• Post-Market Clinical Follow-up (PMCF) Reports
• Summary of Safety and Clinical Performance (SSCP), where applicable
• Ensure the completeness, accuracy, and regulatory compliance of all PMS documentation.

Quality Systems & Continuous Improvement

• Lead CAPA investigations related to post-market issues.
• Support management review processes with PMS performance metrics.
• Drive process improvements and digital transformation initiatives within PMS operations.
• Monitor regulatory changes and assess business impact.

Audit & Inspection Readiness

• Act as the SME during audits and inspections by Notified Bodies, FDA, and other regulatory agencies.
• Lead preparation activities and remediation efforts for audit observations.
• Ensure inspection readiness across PMS-related processes and documentation.

Cross-Functional Collaboration

• Collaborate with:
• Regulatory Affairs
• Clinical Affairs
• Design & Product Development
• Manufacturing
• Customer Service
• Marketing
• Provide strategic input into product lifecycle management and new product introductions.

Qualifications and Experience:

Required

• Bachelor's Degree in B-Tech , Biomedical Engineering, Biotechnology, Quality Management, or related field.

Preferred

• Master's Degree in Engineering, Regulatory Affairs, or Science.

Experience Required

• 10+ years of experience in Medical Device Quality, Regulatory Affairs, Post Market Surveillance, or Vigilance.
• Strong experience with global PMS regulations and reporting requirements.
• Proven track record managing audits, inspections, and cross-functional teams.
• Experience supporting Class II and/or Class III ( Class C & D ) Medical Devices

Key Competencies

1. Technical

• Post Market Surveillance
• Vigilance Reporting
• Complaint Handling
• Medical Device Regulations
• EU MDR & FDA Compliance
• ISO 13485 & ISO 14971
• CAPA & Quality Management Systems

1. Leadership

• Team Leadership & Coaching
• Strategic Thinking
• Stakeholder Management
• Decision Making
• Project & Program Management

Career Level : PMS Lead / Manager

This role is ideal for a seasoned professional with 10+ years of Medical Device industry experience, capable of leading global PMS operations, influencing senior stakeholders, and ensuring end-to-end post-market compliance and patient safety