Senior Counsel, Regulatory Law, MedTech

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: Legal & Compliance Job Sub Function: Law Business Partners Job Category: Professional All Job Posting Locations: Danvers, Massachusetts, United States of America, New Brunswick, New Jersey, United States of America, Santa Clara, California, United States of America, Washington, District of Columbia, United States of America Job Description: We are searching for the best talent to be a Senior Counsel, Regulatory Law, MedTech. 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 The Johnson & Johnson Global Legal Organization (“GLO”) is recruiting for a Senior Counsel, Regulatory Law, MedTech to support Johnson & Johnson MedTech. This position can be based in New Brunswick, New Jersey, Washington, D.C., Santa Clara, California, or Danvers, Massachusetts. Purpose: This Senior Counsel position is for a regulatory attorney within the Med Tech Legal Team of the GLO. 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. You will be responsible for: 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. 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. #LI-Hybrid Required Skills: Preferred 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 The anticipated base pay range for this position is : $150,000.00 - $258,750.00 For Bay Area: $172,000.00 - $297,850.00 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 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 For additional general information on Company benefits, please go to: - 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 Do Not Sell or Share My Personal Information Limit the Use of My Personal Information