Nadira Lotus

Manager, Post Market Surveillance @Argon Medical Devices, Inc.

Plano, TX, US

Lead the global Post-Market Surveillance (PMS) function, ensuring full compliance with EU MDR, MDSAP, and FDA QSR requirements. Drive strategic and operational initiatives across PMS activities, providing cross-functional leadership and supporting regulatory documentation critical to product lifecycle and market authorization.Key Responsibilities:Manage and mentor the PMS team, including performance evaluations, development planning, and training to ensure high-quality deliverables and regulatory alignment.Oversee the planning, development, and timely submission of PMS deliverables, including:Post-Market Surveillance Plans (PMSPs)Post-Market Surveillance Reports (PMSRs)Periodic Safety Update Reports (PSURs)Periodic Review of Experience Reports (PRER)Summary of Safety and Clinical Performance (SSCP)Coordinate and align PMS activities to support the development and maintenance of Clinical Evaluation Reports (CERs), providing critical data inputs such as complaint trends, adverse event analysis, literature surveillance, and PMCF outcomes.Review and approve PMS documentation to ensure regulatory compliance, accuracy, and integration with clinical and risk management files.Participate in Management Reviews by presenting PMS data, trend analysis, and safety/performance indicators to inform strategic business and quality decisions.Lead responses to notified body inquiries and audits regarding PMS processes and documentation.Maintain and monitor internal schedules to ensure PMS documentation is completed within regulatory timelines and organizational priorities.Collaborate with Regulatory Affairs, Clinical Affairs, and Risk Management teams to ensure PMS insights are effectively integrated into technical documentation and regulatory submissions.

California State University-Dominguez Hills

M.Sc., Health Care Science

University of California, Riverside

B.SC, Biology