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| 565038-Global Field Action Lea WI 70 - 100k (J#13313) Education: Bachelors Degree Experience: 4 - 9 years Essential Functions (Responsibilities): This position is responsible for driving and developing standard mechanisms and processes for managing global field actions and coordinating the communication of corrections and removals to global regulatory agencies. Responsibilities include: - Lead development and execution of global field action strategies in compliance with regulatory agencies. - Communicate with implementation teams and provide senior management with key data regarding field actions to help drive decisions - Ensure effective root cause determination, correction and prevention processes are followed. - Work closely with other functional areas (e.g. Marketing, Engineering, Manufacturing, Service) to ensure compliance to applicable regulations for the timely execution of field actions - Ensure Regulatory reporting/documentation is completed and updated as required. Includes but is not limited to: customer communications, initial reports, updates, replies and closure reports. - Lead and support continuous improvement activities assigned, which may include such areas as: Field action process, Risk management, and metrics development/implementation. - Facilitate cross-functional/P/L involvement and escalation. - Liaise with internal personnel and external regulatory bodies to ensure appropriate input into field action strategy and execution - Monitor, report and benchmark industry / regulator field events. - Assist in the identification of safety issues regarding installed base. - Participate in Risk Analysis and approval for safety issues. - Communicate with ECRI and other industry groups regarding initiated field actions. Qualifications/Requirements: - Bachelor's Degree and 4 years experience in a medical device or pharmaceutical industry; or a minimum 8 years of Quality Assurance/Regulatory Affairs experience in medical device or pharmaceutical industry, including: -Applying Corrective and Preventative Action to processes -Handling adverse event and recall issues -Completing Statistical and root cause analysis -- Prior experience using spreadsheet and presentation software - Working knowledge of English language (oral and written) - Must be willing to take a drug test - Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background - Must be legally authorized to work in the United States - Must be willing to work out of an office located in Milwaukee, WI - Must be willing to travel 10% of time Desired: - Experience interfacing with external regulatory agencies (e.g. FDA, Competent Authorities) - Ability to set priorities and drive execution for cross functional teams Knowledge of Quality Management Systems - Strong knowledge of assigned business operations and knowledge of product specific safety standards and work groups *Knowledge and experience applying drug or device laws as well as regulations by external bodies Awareness of local and International Regulatory Agencies - Knowledge of a New Product Introduction process - Ability to work across cultures/poles/sites - Excellent written and verbal communication skills with the ability to communicate business issues in an easy to understand manner - Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging or frustrating circumstances. - Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations - Adaptable/Flexible: Being open to change (positive or negative) in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations - Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others General: Build your career and experience the advantages that come with working for the "World's Most Admired Company" (Fortune Magazine) offering significant opportunities for growth and career advancement! In this role, the Global Field Action Leader will provide guidance to cross functional business teams to ensure GEHC establishes best practice standards in the development and execution of field action strategies. | |||
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