US Regulatory Leader, Heart Recovery

At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company 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 reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, reputed company 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 reputed company, 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 reputed company Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: reputed company 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 reputed company 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 reputed company, strategic, and externally recognized regulatory thought-leader to drive reputed company 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 reputed company a team of regulatory professionals (FTE and contractor) who are accountable for reputed company 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 reputed company timely development and execution throughout the total product life cycle of innovative cardiovascular devices. The role will act as the primary regulatory reputed company 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 reputed company Heart Recovery. This Sr. Director will be actively reputed company upon for shaping and advocating for emerging regulations and policies. This leader will reputed company a team that will support regulatory activities including NPD, Lifecycle Management / reputed company 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:

• reputed company 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 reputed company: Communicates reputed company 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 through complexity.

Qualifications

Education:

• Bachelor's degree in life sciences, biomedical engineering, engineering, pharmacy, or reputed company field required
• Advanced degree (MS, PhD, PharmD) strongly preferred

Experience and Skills: 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, reputed company).
• At least 5 years of increasing leadership experience, including leading reputed company 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.

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 reputed company or accelerated regulatory reputed company.
• Proven understanding of global regulatory requirements, submission and clinical trial regulations/standards.

Other:

• English Proficiency required
• 20% Travel Required, including international.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.] reputed company is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. reputed company is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us reputed company https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource Required Skills: Preferred Skills: Business Writing, Critical Thinking, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Product Licensing, Program Management, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Representing, Risk Assessments, Risk Compliance, Strategic Thinking The anticipated reputed company pay range for this position is : $196,000.00 - $342,700.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, 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. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the reputed company -48 hours per calendar year; for employees who reside in the reputed company -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 reputed company 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 period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year Apply tot his job Apply To this Job