Director of Regulatory Affairs

The Director of Regulatory Affairs provides leadership and oversight for regulatory activities supporting global registrations, market access, and ongoing compliance for a medical device portfolio. This role is responsible for developing regulatory strategies, preparing and managing submissions, and ensuring regulatory requirements are effectively integrated throughout the product lifecycle. The position requires a blend of strategic leadership and hands‑on execution, including direct involvement in complex regulatory submissions and interactions with health authorities. Key Responsibilities Lead regulatory initiatives supporting product development, commercialization, and post‑market activities across the product lifecycle. Develop, author, review, and submit regulatory applications, including 510(k)s, PMAs, and international registration dossiers, ensuring compliance with applicable regulations and standards. Manage regulatory submissions and communications with the U.S. FDA, international regulatory agencies, and notified bodies. Establish regulatory strategies for new products, design changes, and expansion into additional markets while aligning with organizational objectives. Represent Regulatory Affairs on cross‑functional teams, providing guidance on product design, testing requirements, labeling, intended use, and product claims. Monitor and interpret evolving regulatory requirements, guidance documents, and industry trends, translating them into practical regulatory plans. Provide regulatory expertise in design controls, risk management activities in accordance with ISO 14971, and clinical and non‑clinical development efforts. Evaluate product, manufacturing, and process modifications to determine regulatory impact and identify appropriate submission or documentation pathways. Coordinate and support interactions with regulatory authorities, including pre‑submission meetings, responses to agency questions, and regulatory negotiations. Ensure timely and accurate responses to regulatory requests and maintain commitments made to regulatory agencies. Review product labeling, advertising, and promotional content to confirm alignment with regulatory requirements and approved indications. Support quality system activities, including CAPA investigations, change control processes, nonconformance management, and field actions from a regulatory perspective. Participate in regulatory inspections and audits, including preparation activities, inspection support, and follow‑up responses. Provide mentorship and technical guidance to regulatory team members while contributing directly to key regulatory deliverables. Drive continuous improvement initiatives related to regulatory processes, procedures, and best practices. Qualifications Bachelor’s degree in Engineering, Life Sciences, or a related discipline required. Minimum of 8–10 years of Regulatory Affairs experience within a regulated industry, preferably medical devices. Proven experience preparing and leading 510(k) submissions from strategy through clearance. Strong working knowledge of FDA regulations, international regulatory requirements, and medical device compliance frameworks. Experience communicating directly with regulatory agencies and notified bodies. Solid understanding of design controls, product development processes, and lifecycle management principles. #J-18808-Ljbffr ALKU