Senior Director, Post Market Surveillance

Senior Director, Post Market Surveillance leads the global PMS program, providing leadership to establish and sustain the global vision, strategic direction, and long-term roadmap for post market surveillance, vigilance, and regulatory compliance across the organization. Acts as the executive authority for PMS decisions, escalations, and regulatory interactions, ensuring globally harmonized processes aligned with ISO 13485, FDA QSR, and EU MDR. Owns and evolves PMS processes, robust complaint trending, signal detection, and escalation, and oversees global vigilance reporting (EU MIRs, FDA MDRs, Health Canada, MHRA, TGA, PMDA). Leads cross-functional recall teams, maintains recall readiness and crisis response governance, and directs the global HHE process with scientifically sound risk-based assessments. Provides executive oversight for EU MDR post market reporting deliverables (PSURs, PMSRs, trend analyses). Partners with Operations, R&D, and Quality to drive systemic improvements and serves as the executive interface with OEM partners on safety, quality events, and corrective actions. Ensures timely response and closure of OEM SCARs. Influences senior leadership through data-driven insights and strategic recommendations. Performs other duties as required.