Regulatory Affairs & Quality Process Manager
Sirona Medical
Senior Quality Compliance Specialist – MDR Reporting
Edwards Lifesciences
full-time
Posted on:
Location Type: Remote
Location: Remote • California, Massachusetts, North Carolina, Texas • 🇺🇸 United States
Visit company websiteSalary
💰 $80,000 - $113,000 per year
Job Level
Senior
About the role
- Evaluate global complaint information provided and conduct additional investigation as needed
- Prepare and submit MDR reports to FDA
- Manage customer relationship and expectations during course of complaint investigation and resolution process
- Analyze and/or audit complaint data/files and may develop reports
Requirements
- Bachelor's degree plus five (5) years of experience with complaint handling and evaluating complaints for MDR (Medical Device Reporting)
- Medical Device, healthcare, or a related environment/industry experience
- Experience submitting Medical Device Reports
- Proficient knowledge of medical terms and human anatomy
- Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
- Strong knowledge and familiarity with 21 CFR 820 & 803 regulations
- Proven expertise in MS Office Suite and ability to operate general office machinery
- Excellent written and verbal communication skills and interpersonal relationship skills
Benefits
- Competitive salaries
- Performance-based incentives
- Health insurance
- 401(k) matching
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
complaint handlingMedical Device Reporting (MDR)Good Documentation Practices (GDP)21 CFR 820 regulations21 CFR 803 regulationsdata analysisreport developmentmedical terminologyhuman anatomy
Soft skills
customer relationship managementcommunication skillsinterpersonal skillsanalytical skills
