Senior Counsel, Regulatory Law, MedTech

Johnson & Johnson•Santa Clara, CA

1d•Hybrid

About The Position

Johnson & Johnson is seeking a Senior Counsel, Regulatory Law, MedTech to join its Global Legal Organization (GLO). This position will be based in Santa Clara, CA, and will be part of the Global Regulatory Legal Team. The role involves 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 digital health and robotics. Johnson & Johnson is committed to building a world where complex diseases are prevented, treated, and cured, and where treatments are smarter and less invasive, profoundly impacting health for humanity. The company fosters an inclusive work environment that respects diversity and dignity.

Requirements

A J.D. or LL.M. with admission to and good standing with the bar of one state or the District of Columbia is required.
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.
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.

Nice To Haves

Experience with data rights, machine learning, Artificial Intelligence (AI), robotics, and Software as a Medical Device is preferred.
Business Agility
Collaborating
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

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 Global Regulatory 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.

Benefits

Eligibility to participate in the Company’s consolidated retirement plan (pension)
Eligibility to participate in the Company’s savings plan (401(k))
Eligibility to participate in the Company’s long-term incentive program
Vacation – 120 hours per calendar year
Sick time - 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents)
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