Director of Regulatory Affairs

Director, Regulatory Affairs

Position Summary

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.
• Advanced degree preferred.