Associate Director, Regulatory Affairs - Cardiac Rhythm Management

Act as regulatory lead on cross-functional project teams Collaborate with Program Management, R&D, Quality, Clinical, and Operations to ensure regulatory compliance and readiness Mentor and guide junior team members; including directing and coordinating activities of Regulatory Affairs employees under direct and indirect supervision Provide day-to-day management of Regulatory Affairs function for CRM business Establish project priorities, allocating resources and workload Review and edit submissions prepared by Regulatory Affairs personnel Review and sign off on product and manufacturing change submissions Provide Regulatory Affairs training / mentoring to other employees Bachelor's degree or higher Minimum of 10 years of experience in Regulatory Affairs or related fields (e.g., Quality, R&D, Program Management) Demonstrated leadership through project management, mentoring, or direct supervision with at least 3 years of people management experience Experience with regulatory submissions (e.g., 510(k), IDE, PMA, MDR CE Marking, international registrations) Demonstrated ability to effectively work cross-functionally with Program Management, R&D, Clinical, Quality, and/or Operations Prior experience with implantable cardiac devices / Class II and III medical devices Strong communication, collaboration, and organizational skills Experience supporting clinical studies and audits Familiarity with international regulatory requirements Knowledge of CRM products and technologies Support external audits (e.g., FDA, Notified Bodies) and maintain audit readiness Participate in quality system activities and regulatory intelligence efforts Process Improvement & Collaboration Contribute to the development of best practices across the Regulatory Affairs function Support due diligence and integration for new business opportunities