US Regulatory Leader, Heart Recovery

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: Johnson & Johnson Med Tech is recruiting for a Sr, Director, US Regulatory Affairs, Heart Recovery located in Danvers, Massachusetts! About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at About Cardiovascular Are you passionate about improving and growing the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. We are seeking an experienced, strategic, and externally recognized regulatory thought-leader to drive complex regulatory projects, involving cross-functional teams, in support of the organization's business priorities. Knowledge in the field of cardiovascular medical devices with a proven record in regulatory strategy, policy and pre- and post-market submissions, particularly in the US is required. This individual will lead a team of regulatory professionals (FTE and contractor) who are accountable for all product registrations with a focus on the US FDA, in collaboration with cross-functional teams, including R&D, Clinical, Quality, Supply Chain and Global Strategic Marketing, to enable timely development and execution throughout the total product life cycle of innovative cardiovascular devices. The role will act as the primary regulatory lead for interactions with FDA, and will establish industry-leading regulatory approaches that support business objectives and patient access to innovative cardiovascular products. This role has significant market & business level influence and responsibility and is considered a leader and an FDA authority resource within Heart Recovery. This Sr. Director will be actively called upon for shaping and advocating for emerging regulations and policies. This leader will lead a team that will support regulatory activities including NPD, Lifecycle Management / Base Business, and cross-business unit regulatory activities. The right leader will support US market approvals and ensure regulatory compliance for a ground-breaking heart recovery business that will accelerate patient access to life-saving cardiac therapies. Key Responsibilities: • Lead development of regulatory strategies through total product lifecycle management for assigned cardiovascular products • Serve as the primary Regulatory contact for the FDA • Provide subject matter expertise for preparation, review, and submission of regulatory filings including 510k, IDEs, PMAs, HDEs, post-market actions and safety communications, ensuring high-quality regulatory documentation and submissions • Provide regulatory expertise during product development, including development of clinical trial strategies ensuring compliance with relevant clinical and device regulations and standards • Identify and communicate to senior leadership regulatory risks and opportunities across programs and define mitigation strategies that balance patient safety, compliance, and business timelines • Leads, mentors, develops regulatory team members and builds capability across functions • Participate in governance, risk assessments, and go/no-go decisions for critical product development goals Leadership Competencies • Executive Presence: Communicates complex regulatory rationale clearly and confidently to senior leaders and partners. • Critical Thinking: Builds regulatory strategies that align with product lifecycle and global business goals. • Influencing & Partner Management: Drives alignment across cross-functional and regional teams without direct authority. • Critical Leadership: Makes timely, risk-balanced decisions in uncertain regulatory environments and guides teams thro