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Product Surveillance Supervisor

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Job Description:
Provides supervision of the team responsible for Cardiac Rhythm Management (CRM) Complaint Handling and Regulatory Reporting of product complaints. Ensures systems/processes are suitably designed and appropriate staffing is maintained to provide an effective quality system.
The Product Performance Group (PPG) Supervisor will be responsible for supervision of their group as well as individual accomplishment, including but not limited to:
+ Recruits/identifies, interviews and selects organizational talent
+ Mentoring, coaching and developing individuals
+ Demonstrates effective change leadership
+ Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
+ Provides direction and guidance to exempt and non-exempt staff who exercise significant latitude and independence in their assignments
+ Conveys clear expectations to their group and delivers constant results
+ Select projects to support business needs and achieve departmental goals
The Product Performance Group (PPG) Supervisor will work with their group to:
+ Ensure the active, systematic collection and documentation of complaint data or other information about a marketed device complies with all global regulations
+ Ensure compliance to all applicable global regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities
+ Exceed customer expectations by responding to regulatory inquires in a professional and timely manner
+ Keeps the organization's vision and values at the forefront of decision making and action
+ Builds strategic partnerships to further departmental and organizational objectives
+ Monitors department compliance with company policies and procedures
+ Makes decisions regarding work processes or operational plans and schedules to achieve department objectives
+ Assists PPG Manager in developing/maintaining annual budget for department cost center
+ Provides appropriate level of cross-functional and customer-oriented communications regarding the status of department and quality system operation, as well as product performance
Qualifications:
+ Four-year degree, preferably in the healthcare or science fields, and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis
+ Knowledge of global regulations for medical device reporting and complaint handling is a must. Strong written and oral communication skills are required
+ 2+ years of relevant experience, preferably in the medical device industry
+ 2+ years of experience with CAPA
+ Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously
+ Problem-solving and proficient computer skills are required
+ Experience working in a broader enterprise/cross-division business unit model preferred
+ Ability to work in a highly matrixed and geographically diverse business environment
+ Ability to work within a team and as an individual contributor in a fast-paced, changing environment
+ Ability to provide guidance to a team of direct reports
+ Ability to leverage and/or engage others to accomplish projects
+ Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
+ Multitasks, prioritizes and meets deadlines in timely manner
+ Strong organizational and follow-up skills, as well as attention to detail
+ Ability to travel approximately 5%, including internationally
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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