Base salary not specified; cash-based incentive pr...
Fda 21 cfr qsr compliance knowledge
Complaint investigation and analysis skills
Root cause analysis and capa execution
The primary purpose of this role is to execute complaint handling, regulatory reporting, and post-market surveillance processes in compliance with FDA requirements
Job Summary
The primary purpose of this role is to execute complaint handling, regulatory reporting, and post-market surveillance processes in compliance with FDA requirements.
Candidates will perform root cause investigations, risk assessments, and support corrective and preventive actions (CAPA) for medical device products.
The company offers a comprehensive benefits package including medical, dental, vision, life insurance, and immediate 401(k) matching.
Matching Summary
The primary purpose of this role is to execute complaint handling, regulatory reporting, and post-market surveillance processes in compliance with FDA requirements.
Salary
Base salary not specified; Cash-based incentive program available; Comprehensive benefits including medical, dental, vision, disability, life insurance, and 401(k) match
Skills & Requirements
Must-have
FDA 21 CFR QSR compliance knowledge
Complaint investigation and analysis skills
Root cause analysis and CAPA execution
Risk assessment for medical devices
Adverse event reportability determination
Nice-to-have
Cross-functional collaboration abilities
Microsoft Office advanced proficiency
Positive can-do attitude
Continuous improvement mindset
Strong written and oral communication
Key Requirements
Bachelor's degree required or 3 years relevant experience
Minimum 1 year of relevant experience in medical device industry
Knowledge of US and International regulatory bodies