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Manager, Product Monitoring

Company: Integer Holdings
Location: Palm Harbor
Posted on: May 25, 2023

Job Description:

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.At Integer, our values are embedded in everything we do.Customer We focus on our customers' successInnovation We create better solutionsCollaboration We create success togetherInclusion We always interact with others respectfullyCandor We are open and honest with one anotherIntegrity We do the right things and do things rightJob Summary:The position is responsible for compiling and analyzing post market surveillance data for potential corrective action and continued improvement. The position requires reporting adverse events to regulatory agencies as required and closure of investigations within appropriate timeframes. Complaint Handling Process Owner to ensure internal procedures meet all regulatory requirements.Accountabilities & Responsibilities:* Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.* Leads and develops the teams, establishes and maintain the systems needed to execute product monitoring for a category of business.* Assures timely and compliant management of complaint receipt, evaluation and investigation processes.* Communicates complaint investigation results in a timely manner to customers, external regulatory agencies (via FDA MDR and EU vigilance reporting), and to internal management.* Monitors sources of product performance feedback and provides input into CAPA and product risk management processes.* Manages execution of the Post-Market Surveillance (PMS) program and conducts reviews with cross-functional peers and business category leaders.* Evaluate and determine risk of product failure.* Ability to determine adverse events and report to appropriate regulatory agencies as required.* Manages the collection and reporting of product monitoring quality metrics and analytics; coordinates with sites to develop and maintain data for periodic reporting. (via Management Review and PMS).* Interviews, hires, and establishes training plans for direct reports. Provides development and mentoring of the team members.* Serves as a member of the Internal Auditors Team* Performs other functions as required.Education & Experience:Minimum Education: Bachelors in an Engineering, Science or Technology discipline. Master's degree preferred.Minimum Experience: Minimum of 10 years of experience in related medical device/regulatory industry. Experience in design/manufacturing of business category-specific products is preferred.* 5 years direct experience in medical device complaint handling and regulatory agency reporting; field corrective action experience desirable.* 5 years of supervisor/management experience.Knowledge & Skills:Specialized Knowledge:* Solid understanding of industry standards and global regulatory requirements for the management of complaints and field corrective actions.* Understanding of product risk assessment/health hazard; biomedical and clinical application preferred.* Applied knowledge of post-market surveillance, product risk management, and field corrective action practices.* Effective management of time sensitive workflows and simultaneous multiple projects.U.S. Applicants: EOE/AA Disability/Veteran

Keywords: Integer Holdings, Palm Harbor , Manager, Product Monitoring, Executive , Palm Harbor, Florida

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