**Job Description Summary**
Quality Compliance Specialist will be responsible for executing key post-market activities such as preparation of vigilance decision trees, vigilance reporting to National Competent Authorities, follow-up communication with Competent Authorities for all BDX Business Units in line with the regulatory environment.
+ Process European serious incident reports for all business units through the dedicated electronic system and maintain the associated documentation, as required.
+ Support and respond to Competent Authority enquires relating to specific vigilance cases as required.
+ Supporting the on-going review and evolution of the CoE to ensure the process is comprehensive, efficient and reflective of best practice within BD and within the Medical Device industry. The job holder will also support implementing the requirements of the MDR and the IVDR and any other EMEA regulatory requirements in relation to Vigilance.
**Primary Work Location**
BEL Erembodegem – Dorp 86
DEU Heidelberg – Tullastrasse
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.