Edwards Lifesciences
Senior Quality Compliance Specialist - MDR Reporting
Edwards Lifesciences, Oklahoma City, Oklahoma, United States
Overview
Employer Industry: Medical Device Industry
What to Expect
Evaluate global complaint information and conduct necessary investigations, escalating as appropriate
Prepare and submit Medical Device Reporting (MDR) reports to the FDA
Manage customer relationships during the complaint investigation and resolution process
Lead cross-functional meetings to discuss complaint issues and identify root causes
Analyze complaint data and develop reports to improve processes and compliance
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, healthcare, or related industry
Strong knowledge of 21 CFR 820 & 803 regulations
Excellent written and verbal communication skills
Proven problem-solving and critical thinking abilities
Preferred Qualifications
Experience submitting Medical Device Reports
Proficient knowledge of medical terms and human anatomy
Familiarity with Good Documentation Practices (GDP) related to complaint filing
Expertise in MS Office Suite and general office machinery
Substantial knowledge of quality compliance policies and procedures
Benefits
Salary up to $113,000 for highly experienced candidates
Opportunity for career advancement and growth within the organization
100% remote work flexibility within the U.S.
Competitive salaries and performance-based incentives
Comprehensive benefits programs tailored to meet diverse employee needs
Chance to significantly impact patient safety and product quality
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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What to Expect
Evaluate global complaint information and conduct necessary investigations, escalating as appropriate
Prepare and submit Medical Device Reporting (MDR) reports to the FDA
Manage customer relationships during the complaint investigation and resolution process
Lead cross-functional meetings to discuss complaint issues and identify root causes
Analyze complaint data and develop reports to improve processes and compliance
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, healthcare, or related industry
Strong knowledge of 21 CFR 820 & 803 regulations
Excellent written and verbal communication skills
Proven problem-solving and critical thinking abilities
Preferred Qualifications
Experience submitting Medical Device Reports
Proficient knowledge of medical terms and human anatomy
Familiarity with Good Documentation Practices (GDP) related to complaint filing
Expertise in MS Office Suite and general office machinery
Substantial knowledge of quality compliance policies and procedures
Benefits
Salary up to $113,000 for highly experienced candidates
Opportunity for career advancement and growth within the organization
100% remote work flexibility within the U.S.
Competitive salaries and performance-based incentives
Comprehensive benefits programs tailored to meet diverse employee needs
Chance to significantly impact patient safety and product quality
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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