Edwards Lifesciences
Senior Quality Compliance Specialist - MDR Reporting
Edwards Lifesciences, Florida, New York, United States
Overview
Employer Industry: Medical Device Manufacturing Why consider this job opportunity
Salary up to $113,000 for highly experienced candidates Opportunity for career advancement and growth within the organization Work remotely anywhere within the continental U.S. Competitive salaries and performance-based incentives Comprehensive benefits programs to meet diverse employee needs Chance to influence the development of groundbreaking technologies that improve patient outcomes What to Expect (Job Responsibilities)
Evaluate global complaint information and conduct investigations as needed, escalating issues appropriately Prepare and submit Medical Device Reporting (MDR) reports to the FDA Lead projects to improve complaint handling processes and recommend solutions Manage customer relationships and expectations during complaint investigations Analyze and audit complaint data/files and develop reports What is Required (Qualifications)
Bachelor’s degree plus five (5) years of experience in complaint handling and evaluating complaints for MDR; or equivalent work experience Experience in the medical device industry, particularly with cardiovascular, endovascular, or critical care/surgical products Strong knowledge of Good Documentation Practices (GDP) related to complaint filing Familiarity with 21 CFR 820 & 803 regulations Excellent written and verbal communication skills How to Stand Out (Preferred Qualifications)
Experience submitting Medical Device Reports Proficient knowledge of medical terms and human anatomy Demonstrated problem-solving, critical thinking, and investigative skills Substantial knowledge of company policies, procedures, and guidelines relevant to quality compliance Ability to manage confidential information with discretion #MedicalDevices #QualityAssurance #CareerOpportunity #RemoteWork #CompetitivePay We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
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Employer Industry: Medical Device Manufacturing Why consider this job opportunity
Salary up to $113,000 for highly experienced candidates Opportunity for career advancement and growth within the organization Work remotely anywhere within the continental U.S. Competitive salaries and performance-based incentives Comprehensive benefits programs to meet diverse employee needs Chance to influence the development of groundbreaking technologies that improve patient outcomes What to Expect (Job Responsibilities)
Evaluate global complaint information and conduct investigations as needed, escalating issues appropriately Prepare and submit Medical Device Reporting (MDR) reports to the FDA Lead projects to improve complaint handling processes and recommend solutions Manage customer relationships and expectations during complaint investigations Analyze and audit complaint data/files and develop reports What is Required (Qualifications)
Bachelor’s degree plus five (5) years of experience in complaint handling and evaluating complaints for MDR; or equivalent work experience Experience in the medical device industry, particularly with cardiovascular, endovascular, or critical care/surgical products Strong knowledge of Good Documentation Practices (GDP) related to complaint filing Familiarity with 21 CFR 820 & 803 regulations Excellent written and verbal communication skills How to Stand Out (Preferred Qualifications)
Experience submitting Medical Device Reports Proficient knowledge of medical terms and human anatomy Demonstrated problem-solving, critical thinking, and investigative skills Substantial knowledge of company policies, procedures, and guidelines relevant to quality compliance Ability to manage confidential information with discretion #MedicalDevices #QualityAssurance #CareerOpportunity #RemoteWork #CompetitivePay We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
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