US Regulatory Leader, Heart Recovery

Johnson & Johnson Innovative Medicine • Danvers, MA

9d

About The Position

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 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 https://www.jnj.com/medtech 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.

Requirements

• Bachelor’s degree in life sciences, biomedical engineering, engineering, pharmacy, or related field required
• Minimum of 15 years of regulatory affairs experience in the medical device with demonstrated experience leading regulatory strategies across major geographies (U.S., EU, APAC).
• At least 5 years of increasing leadership experience, including leading complex teams or program-level regulatory activities.
• Consistent track record preparing and submitting high‑complexity regulatory filings (e.g., IDEs, PMAs) and interacting directly with the FDA.
• Excellent written and oral communication skills with demonstrated ability to present in senior level environments and to external partners.
• English Proficiency required
• 20% Travel Required, including international.

Nice To Haves

• Advanced degree (MS, PhD, PharmD) strongly preferred
• Deep experience in cardiovascular or implantable device development and regulatory strategy.
• Previous experience at the FDA.
• Experience with combination products, software as a medical device (SaMD), or digital health components.
• Experience with breakthrough device/designation pathways or accelerated regulatory pathways.
• Proven understanding of global regulatory requirements, submission and clinical trial regulations/standards.

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

Benefits

• employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Director