Job Summary
A medical devices supplier is searching for a person to fill their position for a Telecommuting Quality Assurance and Regulatory Affairs Director.
Individual must be able to fulfill the following responsibilities:
- Providing direction and leadership to quality assurance management
- Provide direction and leadership to regulatory affairs personnel
- Participating and supporting in FDA, notified body, supplier and/or other inspections / audits
Qualifications for this position include:
- Ability to travel 30% of the time
- Minimum of a Bachelor of Science degree
- Minimum of 15 years of experience in manufacturing environment
- Minimum of 10 years' experience in the medical device manufacturing industry and 5 years of leadership experience
- Solid understanding of the medical device industry
- Broad regulatory knowledge base including OEM and contract manufacturing requirements
