Senior Counsel, Regulatory Law, MedTech

Johnson & Johnson Innovative Medicine•Santa Clara, CA

1d•Hybrid

About The Position

The Johnson & Johnson Global Legal Organization (“GLO”) is recruiting for a Senior Counsel, Regulatory Law, MedTech to support Johnson & Johnson MedTech. This position will be based in Santa Clara, CA. This Senior Counsel position is for an attorney within the Global Regulatory 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 digital health and robotics. You will be a member of the Global Regulatory Legal Team and collaborate with GLO colleagues around the world.

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.

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

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.
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 period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year