Job Summary
A health technology company is searching for a person to fill their position for a Virtual Medical Device Risk Management Tech Expert.
Candidates will be responsible for the following:
- Assisting in the area of developing organizational policies and standards
- Ensuring products are safe and reliable and in compliance with regulatory requirements
Qualifications for this position include:
- Bachelor's engineering degree, or equivalent experience
- Typically requires 7 plus years of related experience in a medical device or regulated industry
- Expert knowledge of global regulations and requirements for Risk Management, Medical Device, Product Development & Post-Market Management, such as ISO14971, MEDDEV, ISO13485, 21CFR820, EU MDR/PSUR
- Expert knowledge of appropriate global medical device regulations, requirements, and standards
- Direct experience leading Risk Management activities within a Medical Device Product Development Lifecycle