Title: US Regulatory Leader, Heart Recovery Hybrid Work locations Danvers, Massachusetts, United States of America time type Full time Job Description: 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 SubFunction: 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! Remote work options may be considered on a case-by-case basis and if approved by the Company. 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. 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 through complexity. Qualifications Education: - Bachelor’s degree in life sciences, biomedical engineering, engineering, pharmacy, or related 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, 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. 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. 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.] Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, 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. Johnson & Johnson 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 via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource Required Skills: Preferred Skills: Business Writing, Compliance Risk, 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, Strategic Thinking The anticipated base pay range for this position is : $196,000.00 - $342,700.00 Additional Description for Pay Transparency:

Role Description You will own Cadre AI's training and enablement. This means you are responsible for the strategy, content design, and delivery of all client-facing training programs, from live C-suite sessions to on-demand video libraries for clients. Your job is to ensure that every client who receives training from Cadre walks away understanding how to use the AI solutions we build for them and how to lead their teams through the adoption process. Additionally, your team would pioneer trainings on new hot AI topics so that we are always positioned as a thought leader in the space. You will emcee trainings, bring in technical experts as needed, and drive the experience end to end. You will build and launch a premium standalone training offering designed to generate incremental revenue beyond our core consulting engagements. This includes defining the product, building the go-to-market approach, and packaging our training expertise into a scalable service that clients will pay for separately. You will also lead change management efforts externally to help drive adoption with clients as well as internally to help Cadre teams adopt AI-first workflows and tooling as the company scales. This role thrives on someone who is equal parts strategic thinker and exceptional performer - it’s a true player / coach role where you need to be in the details and execute on your own. You need to be charismatic and polished in front of senior executives, highly organized behind the scenes, and relentless about follow-through. You are comfortable designing the training strategy on Monday and delivering a live session to a client's C-suite on Wednesday. You think like an entrepreneur, not a traditional Learning and Development leader, meaning you tailor every engagement to the client's actual business context rather than delivering a generic curriculum. Qualifications - 7+ years of experience in consulting, enablement, training, or client-facing roles. - Proven ability to own a client engagement from end to end. - Strong understanding of the current AI landscape. - Exceptional executive presence and communication skills. - Highly organized and detail-oriented. - Experience building or launching a new service offering, product line, or revenue stream. - Bias toward systems and scalability. - Quick learner with strong technical fluency. - Collaborative leadership style with experience managing at least one direct report. - Ownership mentality and comfort with accountability. Requirements - Own the full lifecycle of client training engagements. - Deliver live training sessions to client C-suite, functional leaders, and end users. - Manage the content library offered to clients. - Coordinate across delivery pods to standardize training best practices. - Design and launch a standalone premium training and change management offering. - Build the go-to-market plan for the premium offering. - Track financial performance of the premium offering. - Lead external (client) and internal (Cadre) change management initiatives. - Partner with leadership to identify areas for training or enablement. Benefits - Work at the frontier of AI adoption. - Own a strategic pillar of the business. - Shape how enterprises adopt AI. - High-trust, high-autonomy environment. - Competitive compensation and equity.

• Join Energy Recovery and Help Build a Sustainable Future • Reporting to the Sr Director Global Water Sales OEM • Responsible for developing sales of the Desal market in the North America West region • Managing all aspects of customer accounts base, from a sales perspective • Develop and strengthen relationships with assigned customers & distribution channels • Assist in understanding the total addressable market as well as market dynamics and trends • Develop relationships with end-users, consultants, OEM's, EPC's, and other relevant shareholders

• Develop sales of the Desal market in the North America West region • Manage all aspects of customer accounts base from a sales perspective • Develop and strengthen relationships with assigned customers & distribution channels • Assist the Sales Manager and Applications Development in understanding the total addressable market and market dynamics • Develop relationships with end-users, consultants, OEM's, EPC's, and other relevant stakeholders • Prepare proposals, presentations, revenue goal settings, and sales training • Monitor market conditions & trends, and competition benchmark • Perform market research to identify PAM, TAM, SAM, SOM and new opportunities • Develop business plans, sales processes, and strategies for assigned markets that ensure attainment of company sales goals and profitability • Gather customers’ feedback and report out • Ensure accurate and complete information is captured in Customer Relationship Management system (CRM)