Senior Counsel, Regulatory Law, MedTech

Job Title Senior Counsel, Regulatory Law, MedTech. Locations New Brunswick, New Jersey; Washington, D.C.; Santa Clara, California; Danvers, Massachusetts. Job Description This Senior Counsel position is for a regulatory attorney within the Med Tech Legal Team of the Global Legal Organization. The responsibilities of this Senior Counsel involve providing strategic legal counsel on a wide range of regulatory and compliance issues to support the development and commercialization of innovative MedTech products, services, and solutions, including complex capital and Class III devices. Responsibilities Advising on legal issues throughout the medical device lifecycle related to regulatory strategy, clinical research, premarket clearance and approval, market access and reimbursement, product launches, commercialization, advertising and promotion, post‑market surveillance, and quality system compliance. Guiding quality and regulatory teams on interactions with regulators and providing legal support during regulatory inspections and discussions of potential field actions. Supervising paralegal review of United States promotional and educational materials as part of a cross‑functional team. Advising on interactions with health care providers, payors, and government officials in compliance with fraud and abuse laws such as the U.S. Anti‑Kickback Statute and industry codes such as the AdvaMed Code of Ethics. Engaging in external regulatory and policy initiatives with trade associations and Johnson & Johnson policy teams. Being a member of the Med Tech Legal Team and collaborating with GLO colleagues around the world. Partnering with health care compliance and privacy colleagues to assess risk, develop policies, and conduct internal training. Traveling within the United States up to 10% of the time. Qualifications & Requirements Have a J.D. or LL.M. with admission to and good standing with the bar of one state or the District of Columbia. Have at least 7 years of experience in the medical devices industry, while working at a law firm, in a regulatory agency, and/or as an in‑house lawyer. Experience advising clients on U.S. regulatory, compliance, and privacy matters, including advertising and promotion, quality, regulatory strategy, clinical research, and cybersecurity issues. Experience with data rights, machine learning, Artificial Intelligence (AI), robotics, and Software as a Medical Device is preferred. Demonstrate excellent strategic and analytical skills and the ability to help business partners find creative and compliant solutions to novel issues. Be an effective communicator with a consultative style capable of interacting with senior business leaders and participating on cross‑functional teams. Have a positive attitude and the ability to work collaboratively within teams and with legal colleagues and business partners at all levels of seniority. Be able to work independently in a fast‑paced environment, with global teams located in multiple time zones. Key Skills Business Agility Collaboration Commercial Laws Compliance Management Corporate Governance Dispute Resolution Lawyering Legal Documents Preparation Legal Services Negotiation Process Improvements Representing Risk Management Strategic Thinking Tactical Planning Technical Credibility EEO Statement 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, please email the Employee Health Support Center (View email address on click.appcast.io) or contact AskGS to be directed to your accommodation resource. Salary & Benefits Base Pay Range: $150,000.00 - $258,750.00; Bay Area: $172,000.00 - $297,850.00. Benefits 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 period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year #J-18808-Ljbffr Johnson & Johnson