Director, Regulatory Affairs - Neurology MedTech

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 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, developing overall regulatory strategy, communicating with regulatory bodies and clients, and leading or expanding new therapy ideas, as applicable. 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 Director will also manage various personnel during projects, acting as a mentor and trainer for junior employees. Responsibilities and Duties Develop and execute regulatory services for client companies, including but not limited to: regulatory submissions (e.g., 510(k), IDE, PMA, IND, BLA, and 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 accurately and timely. Lead/manage business development functions to secure new clients and projects. Develop project and departmental budgets and timelines, as required. Work directly with client companies and regulatory bodies without oversight; provide project leadership while maintaining sole relationship with client companies. Lead people development projects, working alongside team managers. Work collaboratively with other MCRA departments, including clinical, RHEMA, and quality assurance. Work with department heads and executive management to guide progress and development of the regulatory department and company. Required Knowledge, Skills, and Experience Education: Bachelor’s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred. Neurology medical‑device experience required. Minimum ten years of experience in Regulatory Affairs related to development of medical devices, drugs, and/or biologics, developing regulatory deliverables and submissions. Project management and/or managerial experience required. Understanding of clinical research and data analysis. US and/or international regulatory experience/fluency with regulations (e.g., FDA, Notified Body, ISO 13485). Domain‑specific regulatory expertise in a therapeutic area or other MCRA areas of regulatory and scientific expertise. Understanding of the regulatory landscape, breadth of services, interaction across deliverables, and data flows. Strong attention to detail, ability to work individually and in multidisciplinary teams, and with external partners and vendors. Strong written (including medical/technical writing) and verbal communication and presentation skills. Understanding of engineering and biological background to assist with pre‑clinical and clinical strategies and effective communication of these strategies to internal teams and clients. Creative problem‑solving, critical‑thinking, and strong research and analytical skills. Professionalism with customer relations and managing client relationships. Compensation The potential base pay range for this role, when annualized, is $135,300.00 – $376,800.00. The actual base pay offered may vary based on job‑related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part‑time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare benefits. Equal Opportunity Employer IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. EEO Minorities/Females/Protected Veterans/Disabled #J-18808-Ljbffr IQVIA