Direct Hire - Manger - Med Device Safety - Excellent Pay! Immediately Scheduling Interviews!
Kelly Scientific Resources (Chicago North, Illinois)

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Looking for the Best Job you ever had? Base Pay Plus Bonus! Kelly Clinical Research is currently searching for a Medical Device Safety Manager for an expanding global pharmaceutical company located in Round Lake, Illinois. The ideal candidate will possess a RN with three years supervisory background in a pharmaceutical or CRO environments. Please read on and 'Apply Now' to take your career to new heights! Responsibilities: Manage through subordinates the coordination of the activities of the Medical Device Safety Group. 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. 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. 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. Additional: 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. Education RN or MPH - medical/scientific background. Minimum 5 years Clinical Experience. Minimum 3-5 years Medical Device Reporting Experience. Minimum 3 years Supervisory or Managerial Experience. Kelly Scientific Resources Clinical Research is a part of Kelly Scientific Resources, the largest and fastest growing scientific/clinical research staffing company in the world. We provide contract, temp-to-perm and direct hire staffing solutions to the world's most well-respected companies. Disciplines we service include clinical research associates, data management, regulatory affairs, biostatistics and analysis, medical writing, project management, and clinical operations and support.