Regulatory Specialist
Core
Regulatory Specialist supporting FDA submissions (510(k), IDE, PMA) for Class II and III medical devices, specifically orthopedic implants and instruments.
Role type
Regulatory Affairs Specialist (Medical Devices)
Builds
FDA regulatory submissions and documentation for medical device products
Domain
Medical Devices / Orthopedics / Regulatory Affairs
Required skills
FDA regulations knowledge, 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 Office (Word, Excel, PowerPoint, Teams)
Responsibilities
Prepare and review 510(k) submissions, submit documents to FDA, assist in IDE and PMA submissions, review Document Change Orders for compliance, maintain approved PMAs, train new staff on regulatory processes, determine regulatory pathways for new products, review Note-to-File documentation
Seniority
Mid-level (2-5 years experience)