INGENYX- Post Market Surveillance, Vigilance and Complaints Lead

Expected Travel : Up to 10% Requisition ID : 14465

Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026.   Ingenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.   For more information, please visit  Ingenyx.com Position Summary

We are seeking an experienced Post-Market Surveillance, Vigilance & Complaints Lead to manage global post-market activities for medical devices for which the company is a Legal Manufacturer. This role is responsible for complaint handling, vigilance and adverse event reporting, post-market surveillance, signal detection and trending, and Periodic Safety Update Reports (PSURs). The Lead will serve as the primary subject matter expert for post-market regulatory requirements and partner closely with Regulatory Affairs, Quality, Risk Management, Engineering, Operations, and external clinical experts. This senior individual contributor/functional leadership role requires strong technical expertise, regulatory judgment, and the ability to lead cross-functional activities across a global organization. Principal Responsibilities

•    Lead complaint handling process for Legal Manufacturer products, ensuring complaints are appropriately documented, investigated, assessed, and closed. •    Oversee complaint investigations carried out by manufacturing sites, suppliers, contract manufacturers, and technical experts while maintaining Legal Manufacturer accountability. •    Lead global vigilance and reportability assessments and ensure adverse event reports are submitted within applicable timelines. •    Lead the global Post-Market Surveillance program, including PMS Plans/Reports, complaint trending, signal detection, and evaluation of emerging safety or performance issues. •    Own the PSUR process from planning and compilation through cross-functional review and timely completion. •    Ensure post-market information is appropriately incorporated into product risk management, CAPA, Management Review, and other Quality System processes. •    Provide complaint, vigilance, and PMS data for CER, PMCF, SSCP, PSUR, and other clinical evidence activities. •    Partner with Regulatory Affairs, which retains ownership of clinical evidence strategy, CER/CEP governance, PMCF strategy, SSCP governance, clinical vendor management, and final manufacturer approval. •    Support evaluation and execution of field actions, recalls, corrections/removals, FSCAs, and other product safety actions, as applicable. •    Serve as the primary complaint/PMS/vigilance subject matter expert during regulatory inspections, Notified Body audits, and MDSAP audits. •    Monitor evolving global post-market and vigilance requirements and support implementation of applicable regulatory changes.

•    Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related technical or scientific discipline. •    8+ years of medical device industry experience in complaint handling, PMS, vigilance, Regulatory Affairs, Quality, or related post-market functions, including 5+ years of direct post-market experience. •