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

📌 Surveillance Manager (Ahmedabad)
🏢 Zydus Group
📍 Ahmedabad