Base salary not specified; cash-based incentive pr...
Bachelor's degree or 3 years experience
Fda 21 cfr qsr compliance knowledge
Complaint investigation and root cause analysis
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 risk assessments, CAPA investigations, and ensuring timely closure of complaint investigations to protect patient safety.
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, and paid time off
Skills & Requirements
Must-have
Bachelor's degree or 3 years experience
FDA 21 CFR QSR compliance knowledge
Complaint investigation and root cause analysis
CAPA assessment and implementation skills
Adverse event reportability decision making
Nice-to-have
Cross-functional collaboration abilities
Microsoft Office advanced proficiency
Positive can-do attitude
Continuous improvement mindset
Risk assessment for product designs
Key Requirements
Minimum Bachelor's degree required
At least 1 year relevant experience (or 3 years without degree)
Knowledge of FDA 21 CFR QSR requirements
Experience in medical device or regulated industry preferred