BD (Becton, Dickinson and Company) Regulatory Compliance Project Associate in Olen, Belgium
Job Description Summary
This role provides Compliance support to the Customer Advocacy team which is part of the Medication Management Solutions business. The incumbent will be responsible for managing the integration of CME acquisition into the BD infusion compliance model. They will primarily take on a lead role in supporting BD with resolving CME outstanding Compliance issues. They will also be responsible for the notification and evaluation of Incident and Field Safety Corrective Actions of CME products. In doing so, they will act as liaison between CME and BD as well as with competent authorities to ensure complete, accurate and timely reporting as required by regulatory agencies.
This provides a general focus for the requirements of the role but is not exhaustive.
Support integration of CME acquisition into Customer Advocacy process
Lead the resolution of CME outstanding Compliance issues
Determine regulatory reportability of events.
Prepare vigilance reports and communications to Competent Authorities ensuring filing within the required timeframe.
Coordinate the preparation and execution of FSCA/FSN for CME products
Escalate high priority issues as well as identified business risks to the appropriate management level.
Support and participate in audits performed by internal and external (e.g. Notified Body) representatives
Support CME with Regulatory Compliance tasks as required.
Maintain awareness of new and developing trends and requirements related to the evaluation and reporting of medical device related incidents.
Any other ad hoc duties as required by the Regulatory Compliance Manager.
Primary Work Location
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.