VP/Senior Director, Neurology Regulatory Affairs

Washington, United States of America | Full time | Home-based | R1565011 Internal Job Description MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner, IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients make smarter decisions and thrive in the market. Join our team to help shape the future of MedTech. Overview The VP/Senior Director, Regulatory Affairs - Neurology MedTech will be a critical team member supporting regulatory strategy and submissions for the firm’s clientele. The primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, communicating with regulatory bodies and clients, and leading or expanding new therapy ideas, as applicable. The projects may be for companies in MCRA therapeutic areas, other MCRA areas of regulatory and scientific expertise, and/or other growing therapeutic concentrations of MCRA. The VP will also manage various personnel during various projects, as well as act as a mentor and trainer for junior employees. Responsibilities and Duties Develop and execute regulatory services for client companies, including however not limited to: Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs) Regulatory Strategy, Analysis & Development Design, Review & Implement Pre-Clinical Testing Manage Regulatory Affairs staff, facilitate professional development and ensure regulatory projects are completed in an accurate and timely manner. Lead/manage business development functions to secure new clients and projects. Develop projec