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 determining adverse event reportability decisions according to US and International regulations.
The company offers a comprehensive benefits package including medical, dental, vision, disability, 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 package including medical, dental, vision, 401(k) match
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 determination
Nice-to-have
Cross-functional collaboration abilities
Microsoft Office advanced proficiency
Positive can-do attitude
Continuous improvement mindset
Risk assessment for owned designs
Key Requirements
Minimum Bachelor's degree required
At least 1 year relevant experience (or 3 years without degree)