Bracco Medical Technologies

Post Market Surveillance Specialist – Bracco Medical Technologies – Heerlen

Jobid=637301630940612693 (0.0205)

ppJoin our Quality Assurance team and make a direct contribution to product quality, patient safety and regulatory compliance. As a Post Market Surveillance Specialist, you will ensure that product complaints and post-market surveillance activities for our products are followed up carefully, timely and in compliance with applicable requirements /p h3Your Impact /h3 pYou will review complaints, coordinate investigations, support adverse event reporting and contribute to continuous improvement within an international medical device environment. By identifying trends and assessing potential risks, you help ensure the ongoing safety and performance of our products. /p h3What will you do? /h3 ul liManage the end-to-end complaint handling process, including review, investigation, documentation and closure of complaints. /li liAssess complaints for reportability, patient safety impact and potential risks. /li liCoordinate investigations with internal stakeholders, field personnel, distributors and external partners. /li liMonitor complaint and post-market surveillance data to identify trends and emerging issues. /li liSupport adverse event reporting in accordance with applicable regulatory requirements. /li liPrepare analyses and reports for management review and other stakeholders. /li liContribute to the continuous improvement of complaint handling and post-market surveillance processes. /li /ul h3Who are you? /h3 ul liYou have an MBO+ level of working and thinking and experience in a Quality environment; experience with Post Market Surveillance within the medical device industry is an advantage. /li liYou are familiar with regulations and standards such as ISO 13485, EU MDR and other applicable regulatory requirements. /li liYou work accurately, analytically and in a structured manner. /li liYou have strong documentation skills and a keen eye for detail. /li liYou communicate effectively in English and collaborate easily with colleagues across different functions and countries. /li /ul h3Why this role? /h3 pThis position offers the opportunity to work in an international, highly regulated medical device environment where quality and patient safety are central to everything we do. You will play a visible role in maintaining compliance, improving products and supporting safe outcomes for patients and healthcare professionals. /p /p #J-18808-Ljbffr

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