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Description
Job Description Summary Provides quality and regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for Field Actions. Works closely with the Business Segments, Regulatory RA, and Services to provide guidance from initiation to closure of Field Actions. Has knowledge of best practices, in-depth understanding of key business drivers and uses this to accomplish their work. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities The Field Actions RA Leader is responsible for the regulatory actions associated with field actions; business FMIs and Recalls. The individual provides regulatory strategy and directory to the business regarding the regulatory requirements for post market compliance for the field action. They manage customer letter translations and workflows ensuring timely and accurate patient safety notifications are deployed to impacted customers. They work with the product teams (Engineering and Quality) in the development of the recall strategy ensuring all impacted functions are included (commercial, legal, service, operations, regulatory). Develops in-depth knowledge of a discipline while using prior experience and acquired expertise to execute functional policy/strategy. This is an individual contributor with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. Impacts projects, processes and procedures within the Field Action space. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytical thinking required to solve problems. Utilizes Lean principles to help drive recall execution improvements (e.g customer letters distribution, consignee list validation, reconciliation, etc.) Acts as a resource for colleagues with less experience. May lead projects as an output of Kaizens, CAPA actions, or other improvement efforts. Explains information; developing skills to bring team members to consensus around topics within field. Acts are a resource for the business on usage of Smarteeva (Customer Recall Management tool). Guides teams on usage, creating report and works with IT on escalating defects. Have the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Be able to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions. Qualifications Bachelors degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in Quality Assurance or Regulatory Affairs). Preferred Qualifications Experience working in Smarteeva (Customer Recall Management Tool) to upload data and supporting documents, transact within the tool, and create reports. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. Relocation Assistance Provided: No
