Regulatory Specialist
Core
Drafting, submitting, and gaining clearance for FDA 510(k), IDE, and PMA submissions for class II and III medical devices.
Role type
Regulatory Affairs Specialist (Medical Devices)
Builds
FDA regulatory submissions and documentation for orthopedic implant and instrument systems
Domain
Medical device industry, orthopedics, US FDA compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA 510(k) submission preparation, IDE/PMA submission assistance, regulatory pathway determination, document change order review, clinical study data review, SOP development, labeling review
Preferred skills
Engineering degree, orthopedic device experience, Pre-Sub experience, Microsoft Office proficiency
Technologies
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Teams
Responsibilities
Partners with Product Development to prepare 510(k) submissions, submits 510(k) documents to FDA, assists in IDE and PMA completion, reviews Document Change Orders for compliance, maintains approved PMAs, trains new staff on regulatory processes, determines regulatory pathways for new products
Seniority
Mid-level, hands-on IC