Manager, Medical Device Safety

Manager, Medical Device Safety Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. Manage through subordinates the coordination of the activities of the Medical Device Safety Group. Develops and deploys the Medical Device Reporting (MDR) Assessment Process for Baxter. Assures oversight and input (medical closure) into the MDR Assessment Process and ongoing product support to ensure the production of safe and effective products. The scope and influence relates to the introduction of new technologies, services and processes as well as input into established products and the FCA/CAPA process. Manage the activities of the Medical Device Safety Group with responsibility for results in terms of timeliness goals, on-time MDR submissions, site visits, and involved investigations. - Understands and assures conformance to Medical Device Reporting (MDR) Regulations. Develops and deploys an MDR Assessment Process at Baxter- Mentor Product Surveillance Teams in assessments of MDRs.- Performs Medical Closures and assists with Health Hazard Analysis (HHA) assessments in association with the Medical Director. Assesses and advises senior management concerning product safety.- Partners with Pharmacovigilance to ensure adequate information exchange to drive compliance to reporting requirements and consistency in cross-functional investigations.- Interacts frequently with all levels of internal management as well as across functions and business units.- Identifies and manages continuous improvement projects relative to Medical Device Safety that may span multiple sections or departments with the objective of achieving high quality and safe products- Partners with other Clinicians and Sr. Management on various regulatory responses. QUALIFICATIONS: In depth knowledge of MDR reporting, CAPA and FCA processes and their integration into product design, maintenance, process improvement. - Ability to manage/supervise a team of employees.- Strong analytical and problem solving skills.- Strong communication and project management skills.- Good interpersonal/communication/influencing/negotiation skills. MD/RN or other medical/scientific background.Minimum 5 years Clinical Experience. Minimum 3-5 years Medical Device Reporting Experience. Minimum 3 years Supervisory or Managerial Experience. As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V.