Senior Counsel, Regulatory Law, MedTech

Johnson & Johnson•Brunswick, OH

1d•Hybrid

About The Position

Johnson & Johnson’s Global Legal Organization is recruiting a Senior Counsel, Regulatory Law, MedTech, to support Johnson & Johnson MedTech. The role is part of the MedTech Legal Team and provides strategic legal counsel on a broad range of regulatory and compliance matters supporting the development and commercialization of innovative MedTech products, services, and solutions, including complex capital and Class III devices. The position may be based in Washington, D.C.; Santa Clara, California; New Brunswick, New Jersey; or Raritan, New Jersey, and requires travel within the United States up to 10% of the time. The Senior Counsel advises on legal matters across the medical-device lifecycle, including 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. The role also supports regulatory interactions and inspections, reviews promotional and educational materials, advises on health-care-provider, payor, and government-official interactions, and contributes to external regulatory and policy initiatives. The attorney collaborates with legal, compliance, privacy, regulatory, quality, policy, and business colleagues, including global teams.

Requirements

J.D. or LL.M. and admission to, and good standing with, the bar of one state or the District of Columbia.
At least 7 years of experience in the medical devices industry, 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.
Excellent strategic and analytical skills, with the ability to help business partners find creative and compliant solutions to novel issues.
Effective communication and a consultative style, with the ability to interact with senior business leaders and participate on cross-functional teams.
Positive attitude and ability to collaborate with teams, legal colleagues, and business partners at all levels of seniority.
Ability to work independently in a fast-paced environment with global teams located in multiple time zones.

Nice To Haves

Experience with complex capital, data rights, machine learning, artificial intelligence, robotics, and Software as a Medical Device.

Responsibilities

Advise on legal issues throughout the medical-device lifecycle, including 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.
Guide quality and regulatory teams on interactions with regulators and provide legal support during regulatory inspections and discussions of potential field actions.
Supervise paralegal review of U.S. promotional and educational materials as part of a cross-functional team.
Advise on interactions with health care providers, payors, and government officials in compliance with fraud and abuse laws, including the U.S. Anti-Kickback Statute, and industry codes such as the AdvaMed Code of Ethics.
Engage in external regulatory and policy initiatives with trade associations and Johnson & Johnson policy teams.
Collaborate with Global Legal Organization colleagues around the world as a member of the MedTech Legal Team.
Partner with health care compliance and privacy colleagues to assess risk, develop policies, and conduct internal training.
Travel within the United States up to 10% of the time.

Benefits

Eligibility to participate in the company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the company’s long-term incentive program.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington.
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 a child’s birth, adoption, or foster care placement.
Bereavement Leave: 240 hours for an immediate family member and 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.