(Contract) Manager, Quality and Regulatory Affairs

Kymanox is looking for a Contract Quality and Regulatory Manager to support one of our projects for 1 year. The ideal candidate will have a bachelor's degree in a science-related field and 10-15 years of experience working in Quality Assurance with medical devices and 5 years of Regulatory Affairs experience.

Requirements

• Develops and directs regulatory strategies for 510(k) and CE Marked medical devices
• Develops, supports, and maintains the 510K) submission to the FDA
• Provides onsite senior leadership to project teams
• Leads planning and execution of quality assurance events
• Leads the effort to develop a QMS that is compliant to 21 CFR 820/QMSR, ISO 13485 and MDR 745/2017

Benefits

• Competitive pay rate
• Opportunity to work on a variety of projects and gain learnings
• Collaborative team environment
• Professional development and growth opportunities