Senior Manager, Clinical Product Quality – Medical Device, Complaint Handling, Cardiovascular RN
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Job Description
Senior Manager providing clinical guidance on medical-device complaints, surveillance, and risk management. Supporting Edwards’ implantable heart-failure technology and regulatory quality outcomes.
Responsibilities:
- Provide medical/clinical guidance to complaint investigators and engineers on event interpretation, investigation, coding, regulatory reporting, and complaint closure
- Author and/or review complaint conclusions, closure statements, and customer letters
- Assist with and help manage Imaging Reviews
- Educate complaint investigators about events and potential health risks
- Interpret complaint data for investigators, engineers, and Quality personnel
- Author clinically based, product-specific scripts for complaint investigations
- Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses, hospital staff, and customers to support investigations and resolution
- Train complaint investigators on patient anatomy, medical conditions, IHFM products, and procedures
- Provide complaint training to Sales, Marketing, and other customer-facing roles
- Maintain the Decision Rationale Matrix with the VP Product Safety and/or Director of Quality
- Review complaint codes and FDA Medical Device Reports and assist with reporting decisions
- Analyze and interpret complaint data for product lines, business units, regulatory submissions, agency requests, and management reports
- Perform Complaint Trending Analyses and participate in Quality Metrics Review and Quality Data Review meetings
- Communicate complaint data and clinical information to Quality, Manufacturing, and New Product Development teams
- Provide clinical guidance for FMEAs and Risk Management Worksheets
- Provide clinical input to Product Risk Assessments and participate in Risk Management Councils and Quality Boards
- Aid responses to regulatory agencies regarding complaint and Risk Management issues
Requirements:
- Bachelor’s degree plus 10 years of relevant experience or equivalent work experience based on Edwards’ criteria
- Registered Nurse (RN) - current state license active or expired
- Cardiac patient care experience (e.g. cardiac care, ICU, OR, or cardiovascular interventions)
- Medical device industry experience in Quality/Compliance, with a strong preference for complaint handling, complaint investigation, and/or post-market surveillance
- RN with Cath Lab, CVOR, or CVICU nursing experience
- Expert knowledge of the FDA’s Quality System Regulations and experience working within a Quality Management System
- Strong working knowledge of Medical Device regulations, including FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR, CMDR, MDD 93/42/EEC, and other applicable regulatory requirements
- Demonstrated subject matter expertise in clinical product quality, complaint handling, post-market surveillance, risk management, escalation, field action or related quality processes
- Proven successful project management and cross-functional leadership skills
- Ability to read and interpret Product Instructions for Use, Training and Procedure Manuals
- Ability to write routine MDR (Medical Device Reports)/MIR (Manufacturer Incident Report) and routine correspondence
- Ability to interpret patient medical records and clinical data to assess adverse events and potential device-related risks
- Ability to speak effectively before groups of employees of organization
- Ability to provide technical guidance, coaching, and feedback to peers and cross-functional partners without direct people-management responsibility
- Experience in developing or delivering training programs
- Knowledge of computer application programs including Excel, PowerPoint and Word
- Excellent written and oral English communication skills
Benefits:
- Competitive salaries
- Performance-based incentives
- A wide variety of benefits programs to address the diverse individual needs of employees and their families
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