Base: $106,500 to $159,750; bonus/equity: discreti...
Fully remote
Quality management system (qms)
Iso 13485
Fda qsr
Lead the development, implementation, and maintenance of our Quality Management System (QMS) and oversee regulatory submissions for medical devices and life science products
Job Summary
Lead the development, implementation, and maintenance of our Quality Management System (QMS) and oversee regulatory submissions for medical devices and life science products.
Ensure company-wide compliance with all relevant quality and regulatory standards and serve as the primary liaison with regulatory agencies and notified bodies.
This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.
Matching Summary
Lead the development, implementation, and maintenance of our Quality Management System (QMS) and oversee regulatory submissions for medical devices and life science products.
Salary
Base: $106,500 to $159,750; Bonus/Equity: discretionary performance-based bonus; Benefits: medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time
Skills & Requirements
Must-have
Quality Management System (QMS)
ISO 13485
FDA QSR
regulatory submissions
risk management activities
post-market surveillance
Nice-to-have
stealth group
human and planetary health
cross-functional teams
fast-paced environment
Key Requirements
Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field
Minimum of 10 years of progressive experience
Proven track record of successful FDA 510(k) submissions
Strong knowledge of ISO 13485, FDA QSR, ISO 14971, MDR