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

This is a fully remote position, open to applicants in Arizona, +9 more states.

📋 Description

• Offer medical and clinical guidance to complaint investigators and engineers regarding event interpretation, investigation, coding, regulatory reporting, and closure of complaints.

• Compose and/or review conclusions, closure statements, and customer correspondence related to complaints.

• Assist in managing Imaging Reviews.

• Educate complaint investigators on events and the associated potential health risks.

• Analyze complaint data for investigators, engineers, and Quality personnel.

• Write clinically focused, product-specific scripts for use in complaint investigations.

• Gather and assess information from clinical specialists, sales personnel, physicians, nurses, hospital staff, and customers to support investigations and resolutions.

• Provide training to complaint investigators on topics such as patient anatomy, medical conditions, IHFM products, and relevant procedures.

• Deliver complaint training to Sales, Marketing, and other customer-facing teams.

• Maintain the Decision Rationale Matrix in collaboration with the VP of Product Safety and/or Director of Quality.

• Examine complaint codes and FDA Medical Device Reports, aiding in the reporting decision process.

• Analyze and interpret complaint data across product lines, business units, regulatory submissions, agency requests, and management reports.

• Conduct Complaint Trending Analyses and engage in Quality Metrics Review and Quality Data Review meetings.

• Relay complaint data and clinical information to Quality, Manufacturing, and New Product Development teams.

• Provide clinical guidance for Failure Mode and Effects Analyses (FMEAs) and Risk Management Worksheets.

• Contribute clinical insights to Product Risk Assessments and participate in Risk Management Councils and Quality Boards.

• Assist in responding to regulatory agencies concerning complaints and Risk Management issues.

⛳️ Requirements

• A Bachelor's degree along with 10 years of relevant experience or equivalent work experience as per Edwards' criteria.

• Current or expired Registered Nurse (RN) license in the relevant state.

• Experience in cardiac patient care (e.g., cardiac care, ICU, OR, or cardiovascular interventions).

• Background in the medical device industry particularly in Quality/Compliance, with a strong preference for complaint handling, investigation, and/or post-market surveillance.

• RN with experience in Cath Lab, CVOR, or CVICU nursing.

• In-depth knowledge of the FDA’s Quality System Regulations and experience in a Quality Management System.

• Strong familiarity with Medical Device regulations, including FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR, CMDR, MDD 93/42/EEC, and other relevant regulatory requirements.

• Proven subject matter expertise in clinical product quality, complaint handling, post-market surveillance, risk management, escalation, field actions, or related quality processes.

• Demonstrated ability in successful project management and cross-functional leadership.

• Capability to read and interpret Product Instructions for Use, Training, and Procedure Manuals.

• Proficiency in writing routine Medical Device Reports (MDR) and Manufacturer Incident Reports (MIR), along with standard correspondence.

• Ability to interpret patient medical records and clinical data to evaluate adverse events and potential device-related risks.

• Strong public speaking skills to effectively communicate before groups of employees within the organization.

• Capacity to provide technical guidance, coaching, and feedback to peers and cross-functional partners without direct management responsibilities.

• Experience in developing or delivering training programs.

• Proficient in computer applications including Excel, PowerPoint, and Word.

• Excellent written and oral communication skills in English.

🏝️ Benefits

• Competitive salary packages.

• Incentives based on performance.

• A diverse range of benefits programs tailored to meet the individual needs of employees and their families.