Edwards Lifesciences
Senior Quality Compliance Specialist - MDR Reporting
Edwards Lifesciences, North, South Carolina, United States, 29112
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 U.S. Involvement in innovative technologies that impact patient care globally Comprehensive benefits programs to meet diverse employee needs Supportive and collaborative work environment focused on quality and compliance What to Expect
Assess and investigate complaint information, escalating as necessary Evaluate complaints for Medical Device Reporting (MDR) and prepare submissions to the FDA Manage customer relationships during the complaint investigation and resolution process Lead weekly meetings with cross-functional teams to address complaint issues Analyze complaint data and develop reports to improve processes and practices What is Required
Bachelor’s degree plus five (5) years of experience in complaint handling and evaluating complaints for MDR Experience in the medical device industry, particularly with cardiovascular, endovascular, or critical care/surgical products Strong understanding of FDA regulations and Good Documentation Practices (GDP) Excellent written and verbal communication skills Proven problem-solving and critical thinking abilities How to Stand Out (Preferred Qualifications)
Experience in submitting Medical Device Reports Proficiency in medical terminology and human anatomy Familiarity with 21 CFR 820 & 803 regulations Expertise in MS Office Suite and general office machinery Knowledge of the employer's policies and procedures relevant to quality compliance 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 U.S. Involvement in innovative technologies that impact patient care globally Comprehensive benefits programs to meet diverse employee needs Supportive and collaborative work environment focused on quality and compliance What to Expect
Assess and investigate complaint information, escalating as necessary Evaluate complaints for Medical Device Reporting (MDR) and prepare submissions to the FDA Manage customer relationships during the complaint investigation and resolution process Lead weekly meetings with cross-functional teams to address complaint issues Analyze complaint data and develop reports to improve processes and practices What is Required
Bachelor’s degree plus five (5) years of experience in complaint handling and evaluating complaints for MDR Experience in the medical device industry, particularly with cardiovascular, endovascular, or critical care/surgical products Strong understanding of FDA regulations and Good Documentation Practices (GDP) Excellent written and verbal communication skills Proven problem-solving and critical thinking abilities How to Stand Out (Preferred Qualifications)
Experience in submitting Medical Device Reports Proficiency in medical terminology and human anatomy Familiarity with 21 CFR 820 & 803 regulations Expertise in MS Office Suite and general office machinery Knowledge of the employer's policies and procedures relevant to quality compliance 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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