Base salary not specified; cash-based incentive pr...
Fda 21 cfr qsr compliance knowledge
Complaint investigation and analysis
Root cause investigation execution
The primary purpose of this role is to execute and support complaint handling, regulatory reporting, and post market surveillance processes in compliance with FDA regulations
Job Summary
The primary purpose of this role is to execute and support complaint handling, regulatory reporting, and post market surveillance processes in compliance with FDA regulations.
Candidates will be responsible for performing root cause investigations, risk assessments, and CAPA activities while ensuring timely closure of complaints to meet patient safety standards.
The company offers a comprehensive benefits package including medical, dental, vision, life insurance, and immediate eligibility for a 401(k) plan with company matching.
Matching Summary
The primary purpose of this role is to execute and support complaint handling, regulatory reporting, and post market surveillance processes in compliance with FDA regulations.
Salary
Base salary not specified; Cash-based incentive program available; Comprehensive benefits including medical, dental, vision, 401(k) match
Skills & Requirements
Must-have
FDA 21 CFR QSR compliance knowledge
Complaint investigation and analysis
Root cause investigation execution
CAPA assessment and support
Adverse event reportability assessment
Microsoft Office proficiency
Nice-to-have
Cross-functional collaboration skills
Strong written and oral communication
Ability to work independently
Positive can-do attitude
Continuous improvement mindset
Key Requirements
Bachelor's degree required or 3 years relevant experience
Minimum 1 year of relevant experience in medical device industry
Experience with FDA regulations and Quality Management Systems