Senior Manager, Clinical Product Quality – Medical Device, Complaint Handling, Cardiovascular RN

Edwards Lifesciences

Senior Manager providing clinical guidance on medical-device complaints, surveillance, and risk management. Supporting Edwards’ implantable heart-failure technology and regulatory quality outcomes.

Posted 9/3/2026full-timeRemote • Arizona, California, Colorado, Florida, Illinois, Minnesota, New Jersey, North Carolina, Texas, Washington • 🇺🇸 United StatesSenior💰 $145,000 - $205,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in complaint handling, regulatory reporting, and clinical guidance within the medical device industry. Proficient in analyzing complaint data, conducting training, and ensuring compliance with FDA regulations and quality management systems.

Highest-signal resume keywords

Registered Nurse (RN)Medical Device Industry ExperienceExpert Knowledge of FDA Quality System RegulationsComplaint Handling and InvestigationProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Complaint Data AnalysisRegulatory ReportingClinical GuidanceRisk ManagementComplaint Trending AnalysisMedical Device RegulationsPatient Medical Record InterpretationTraining Program DevelopmentMDR/MIR WritingQuality Management System Knowledge

Soft Skills

Effective CommunicationCross-Functional LeadershipCoaching and FeedbackTraining DeliveryPublic Speaking

Tools & Technologies

ExcelPowerPointWord

Certifications & Qualifications

Registered Nurse (RN)

Industry Keywords

Complaint InvestigationPost-Market SurveillanceQuality ComplianceCardiac Patient CareISO 13485ISO 14971EU MDRFDA 21 CFR 820CMDRMDD 93/42/EEC

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of employees and their families