Post Market Surveillance Specialist

divh2Post Market Surveillance Specialist/h2pThe Post Market Surveillance Specialist is responsible for monitoring the performance and safety of IPG Medical devices in post-market settings to ensure compliance with global regulatory requirements and to maintain high standards of quality and patient safety. This role works directly with customers to gather accurate complaint information and supports failure analysis, adverse event investigations, and regulatory reporting. The specialist collaborates cross-functionally to identify trends, drive corrective and preventive actions, and promote continuous improvement throughout the product lifecycle./ppKey Responsibilities/pulliMonitor and evaluate the performance of medical devices in post-market settings to ensure compliance with applicable regulatory requirements and to maintain high levels of safety and quality./liliWork directly with customers to obtain complete and accurate complaint information and to support failure analysis activities./liliConduct thorough and timely investigations of adverse events and complaints related to medical devices./liliCollaborate with cross-functional teams to gather and analyze data, identify trends, and support the implementation of corrective and preventive actions (CAPA)./liliDevelop, maintain, and continuously improve post-market surveillance procedures and processes to ensure compliance with regulatory standards./liliMaintain accurate, detailed, and audit-ready records of post-market surveillance activities, analyses, and findings./liliCommunicate with regulatory agencies and respond to inquiries or requests related to post-market surveillance activities./liliParticipate in internal and external audits and inspections to demonstrate compliance with regulatory requirements./liliStay current on industry regulations, standards, and best practices related to post-market surveillance and communicate relevant updates to internal teams./liliProvide guidance and support to internal stakeholders on post-market surveillance requirements, processes, and regulatory expectations./liliIdentify opportunities for improvement and drive continuous improvement initiatives to enhance the safety, quality, and performance of IPG Medical devices./liliAct as a subject matter expert on post-market surveillance and regulatory compliance for IPG Medical products./li/ulpPromote a culture of patient safety, quality, and continuous improvement across the organization./ppQualifications/pulliBachelors degree or equivalent relevant work experience required./liliAt least 3- 5 years of experience in post-market surveillance within the medical device industry./liliStrong knowledge of medical device regulations and post-market surveillance requirements./liliDemonstrated attention to detail and ability to manage complex documentation in a regulated environment./liliStrong analytical, communication, and cross-functional collaboration skills./li/ul/div