Requirements
- Bachelor's degree in a scientific, engineering, or technical field
- At least three years of experience in quality or regulatory affairs within the medical device industry
- Experience with corrective and preventive actions (CAPA), risk assessment methods, and FDA recordkeeping requirements
- Excellent written communication and organizational abilities
- Familiarity with quality standards including ISO 14971, ISO 13485, ISO 9001, and 21 CFR Part 820
Nice to Have
- Proven ability to resolve complex issues by evaluating system dynamics, considering stakeholder viewpoints, and implementing effective field response strategies
- High attention to detail and adaptability in a dynamic, fast-moving work setting
Work Arrangement
Hybrid
