Senior Manager, Clinical Product Quality - Medical Device/Complaint Handling & Cardiovascular RN

This position offers the flexibility of being fully remote, but the selected candidate must be currently residing within the United States. Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As a Senior Manager, Clinical Product Quality, you will be a member of Complaint Handling and Post Market Surveillance/Risk Management team to provide clinical guidance/clinical expert knowledge to Quality, Engineering and other cross functional teams to understand the nature of complaints and possible health risks. In this role you will ensure appropriate investigation of product complaints and adverse events, in order to escalate potential manufacturing, design, labeling and training issues. You will also follow standard practices and procedures in analyzing data, interpreting and drawing conclusions, with the objective of gathering key information and communicating to cross-functional teams who will utilize the information for improvement of product and procedural outcomes. How you will make an impact: Provides medical/clinical guidance to complaint investigators and engineers related to event interpretation, event investigation, proper coding, required regulatory reporting (Medical Device Reports, Medical Device Vigilance, etc.), and complaint closure. Author and/or review complaint conclusions/closure statements and customer letters. May assist with and help manage Imaging Reviews  Educates complaint investigators to understand nature of events and possible health risks  Interprets complaint data for complaint investigators, engineers, and other Quality department personnel  Authors clinically based product specific scripts to guide complaint investigators in appropriate investigational paths  Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution Provides training to complaint investigators on patient anatomy and medical conditions, and IHFM (Implantable Heart Failure Management) products and procedure  Provides complaint training to Sales, Marketing and other customer facing roles  Works with VP Product Safety and/or Director of Quality to maintain Decision Rationale Matrix to guide complaint investigators with reporting decisions.  Reviews complaint codes and FDA Medical Device Reports, reviews and assists with reporting decisions  Authors and/or reviews complaint conclusions/closure statements and customer letters  Analyzes and interprets complaint data for a specific product line, business unit, regulatory submissions, regulatory agency requests, and/or management report  Performs Complaint Trending Analyses and participates in Quality Metrics Review and Quality Data Review meetings where complaints are discussed  Communicates complaint data and relevant clinical information to internal customers in quality, manufacturing and new product development in support of complaint investigations  Participates in review of/provides clinical guidance for FMEAs (Failure Mode & Effects Analysis) and Risk Management Worksheets Provides clinical input to Product Risk Assessments, and participate in Risk Management Councils and Quality Boards  Aid in response to Regulatory Agencies who inquire about complaint /Risk Management related issues What you'll need (Required):   Bachelor’s degree plus 10 years of relevant experience or equivalent work experience based on Edwards’ criteria  Registered Nurse (RN) -