Fibrogen is seeking a Manager for its Device Quality Systems team who will ensure regulatory compliance and uphold quality standards throughout the lifecycle of Class III medical devices. The ideal candidate will have significant experience in medical device quality systems, particularly with Class III implantable devices, and possess a thorough understanding of relevant regulations
Job Summary
This role is pivotal in ensuring regulatory compliance and supporting quality across the lifecycle of Class III medical devices.
The position involves leading supplier audits, managing quality documentation, and driving continuous improvement initiatives within the Implantable Device Unit.
Biogen offers a competitive benefits package including up to $10,000 in tuition reimbursement, equity incentives, and comprehensive health coverage.
Matching Summary
Match Score: 85
Fibrogen is seeking a Manager for its Device Quality Systems team who will ensure regulatory compliance and uphold quality standards throughout the lifecycle of Class III medical devices. The ideal candidate will have significant experience in medical device quality systems, particularly with Class III implantable devices, and possess a thorough understanding of relevant regulations.
Salary
Base: $111,000.00-$149,000.00; Bonus/Equity: Short-term cash bonus and equity incentive opportunities available; Benefits: Medical, Dental, Vision, Life insurance, 401(k) match, Tuition reimbursement up to $10,000
Skills & Requirements
Must-have
Class III implantable medical device experience
FDA QMSR and ISO 13485 knowledge
Supplier audit and qualification leadership
Cross-functional CAPA activity management
Electronic document control system familiarity
Nice-to-have
Strong analytical mindset for complex regulations
Proactive culture of continuous improvement
Excellent communication and organizational skills
Collaborative approach with regulatory teams
Advanced degree in relevant field
Key Requirements
Bachelor's degree in relevant field
At least 5 years in medical device quality systems
At least 2 years with Class III implantable devices