Regulatory Associate
Core
Assisting in drafting, submitting, and gaining FDA clearance for medical device submissions (510(k), IDE, PMA) for class II and III products.
Role type
Regulatory Affairs Associate
Builds
FDA regulatory submissions and documentation for orthopedic medical devices
Domain
Medical devices / Orthopedics / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Knowledge of US Code of Federal Regulations Title 21, Medical device industry experience, Regulatory Affairs experience, Microsoft Office proficiency, Time management
Preferred skills
Engineering degree, Orthopedic medical device experience
Technologies
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Teams
Responsibilities
Partnering with Product Development to prepare and review 510(k) submissions, Preparing final 510(k) submissions and obtaining management approvals, Submitting 510(k) documents and responding to the FDA, Assisting in the completion of IDE submissions for clinical trials, Helping to prepare PMA packages including non-clinical, manufacturing, and clinical sections, Reviewing Document Change Orders for Regulatory compliance, Performing routine maintenance of approved PMAs including coordination of supplements and Annual Reports, Obtaining and reviewing clinical study data for IDE and PMA reporting
Seniority
Entry-level (0-2 years experience)