Director, Risk Management

Job Advertised by Pharmadiversity Job Board - The Director, Risk Management leads a team of Risk professionals in assessing the degree of risk associated with the use of medical devices designed and / or manufactured by GE Healthcare (GEHC). Risk Management is an integral part of the product development process over the commercial life of the product and includes Identify hazards and hazardous situations Estimating the associated risk Evaluating the risk Controlling the risk Monitoring the effectiveness of the control o Key responsibilities/essential functions include: Lead the review and evaluation of existing and proposed business activities to determine potential risk exposure Develop management reports to qualify and monitor risks to ensure risk responses are timely and effective Determine the most effective methods for handling risk exposures and recommend mitigation to senior management Decompose hazards into lower level hazards and hazardous situations Total product lifecycle monitoring - linking product development risk management to post-market risk assessments Develop and drive improvements to overall Risk Management processes and documentation to provide clear flow down of regulations Establish new and enhance existing relationships with risk management stakeholders to all levels to promote understanding and effective application of the process. Maintain and enhance cross-functional team relationships, including working with other project teams to ensure a real-time communication of issues as related to Risk Management Educate, train, advise and coach business leaders and QA/RA practitioners on the related regulations, procedures and work instructions Work closely with the Clinical/Medical professionals to assure their input is foundational to the hazards and harm inputs to risk management Assure probability of occurrence is consistently applied during failure investigation and risk analysis Recruit, mentor, coach and train direct and indirect reports on activities within area of responsibility Quality Specific Goals: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position 2. Complete all planned Quality & Compliance training within the defined deadlines 3. Identify and report any quality or compliance concerns and take immediate corrective action as required 4. Ensure that specified risk management requirements are met though knowledge & understanding of GEHC Risk Management Procedures and Work Instructions; operate within them in guiding and facilitating product teams that control the design and manufacture of the device. Required Qualifications: Bachelor s degree in scientific / clinical discipline or engineering, and a minimum of 7 years of progressively more responsible Quality Assurance or Regulatory Affairs experience in the medical device, pharmaceutical or.... br/ br/ * For application attention if web source is requested please use PharmaDiversity or PharmaDiversity Job Board. br/ br/ APPLY FOR THIS JOB by going to ...http://www.pharmadiversityjobboard.com/view_job.php?post_id=583072&tag=aje