Manager, Regulatory Affairs
Core
Managing FDA submissions (510(k), IDE, PMA) for class II and III medical devices to ensure regulatory clearance and approval for marketing.
Role type
Manager, Regulatory Affairs
Builds
Regulatory clearance and approval for medical device products
Domain
Medical Devices / Orthopedic / Spinal
Deliverable
client delivery
Required skills
FDA submission preparation, 510(k) clearance, IDE/PMA approval, regulatory strategy, project management, compliance with 21 CFR, document change order review, manufacturing process oversight
Preferred skills
Master's degree, orthopedic or spinal device experience, panel-track PMA experience
Technologies
None stated
Responsibilities
Guide US Regulatory team in preparing and filing submissions, develop team expertise in project management and writing, create optimized regulatory strategies, work with cross-functional teams to obtain information, review and approve document change orders, review product labeling, provide oversight of manufacturing changes, assist in developing SOPs, attend FDA meetings
Seniority
Manager, hands-on IC