The role ensures new product development activities follow a 21 CFR Part 4 compliant quality system in accordance with FDA and EU MDR regulations
Job Summary
The role ensures new product development activities follow a 21 CFR Part 4 compliant quality system in accordance with FDA and EU MDR regulations.
This position provides guidance to local staff and collaborates with global functions to govern quality-related business processes throughout the entire combination product lifecycle.
Total compensation includes base salary ranging from $143,000 to $169,000 plus potential incentive compensation and equity.
Matching Summary
The role ensures new product development activities follow a 21 CFR Part 4 compliant quality system in accordance with FDA and EU MDR regulations.
Salary
Base: $143,000 - $169,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Not specified
Skills & Requirements
Must-have
21 CFR Part 4 compliance expertise
Design Control process management
ISO 13485 and ISO 14971 knowledge
Vendor audit and management experience
Six Sigma problem solving skills
Nice-to-have
Experience with drug-delivery products
Knowledge of embedded software systems
Connected health solutions background
Strong stakeholder influence skills
Key Requirements
Bachelor's degree in engineering or life sciences
Minimum 5 years medical device quality experience
2 years practical R&D Quality experience
Periodic domestic and international travel required