Director of Regulatory Affairs

Sr. Manager / Director, Regulatory Affairs Relocation Required to Southern CA Role Overview We are seeking an experienced regulatory affairs leader to drive strategy, oversee submissions, and guide interactions with global health authorities. This individual will play a pivotal role in ensuring regulatory success for all Medical Device submissions. Key Responsibilities Lead Regulatory Strategy & Execution Define and deliver comprehensive global regulatory strategies supporting product development and lifecycle goals. Serve as the primary regulatory voice on cross-functional project teams, influencing development plans, labeling, and compliance initiatives. Review, approve, and ensure accuracy of documentation supporting product submissions and approvals. Provide leadership and mentorship to regulatory team members, fostering professional growth and regulatory excellence. Regulatory Submissions Direct the planning, authoring, and coordination of global submissions, including IDEs, 501k's and PMA's, and annual reports. Partner with subject matter experts to ensure submissions meet technical, scientific, and regulatory standards. Troubleshoot and resolve challenges that arise during submission preparation and review. Health Authority Engagement Lead communications and meetings with the FDA, EMA, and other regulatory bodies globally. Prepare briefing packages, coordinate Q&A responses, and manage submission-related interactions. Cross-Functional Collaboration Align regulatory deliverables with broader program timelines and corporate milestones. Partner closely with R&D, Quality, Clinical, and Commercial teams to enable a unified approach to development and compliance. Qualifications Education Bachelor’s degree in a scientific or technical discipline required. Advanced degree preferred. Experience Minimum 7 years of industry experience, with at least 4 years in Regulatory Affairs focusing on Medical Devices. Demonstrated success in preparing and leading global regulatory submissions (510k's and/or PMA's) and managing regulatory authority interactions. Previous leadership experience with direct reports or cross-functional teams strongly desired. #J-18808-Ljbffr Bridgeway Partners, Inc.