Senior Regulatory Affairs Specialist (Columbia, MD)
Core
Lead regulatory submissions and strategies for Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/P) and device-led combination products.
Role type
Senior Regulatory Affairs Specialist (HCT/P & Combination Products)
Builds
FDA 510(k) submissions, Pre-Subs, and compliant promotional materials for medical devices and biologics.
Domain
Medical Devices / Biologics / Regulatory Compliance
Required skills
FDA 510(k) submission authoring, Pre-Sub meeting leadership, HCT/P (21 CFR 1271) expertise, change control assessment, audit/inspection support, policy drafting, FDA liaison
Preferred skills
Regulatory Affairs Certification (RAC Devices), deep expertise in device-biologics combination products
Technologies
FDA 21 CFR 1271, FDA 510(k), Pre-Sub (Q-Sub)
Responsibilities
Lead regulatory strategy for new HCT/P and combination product projects; Author FDA 510(k) and Pre-Sub submissions; Review and approve advertising/promotional materials; Support FDA audits and inspections; Draft and maintain regulatory policies; Monitor regulatory landscape changes
Seniority
Senior, hands-on IC
