Senior Counsel, Regulatory Law, MedTech
About The Position
Johnson & Johnson’s Global Legal Organization is recruiting a Senior Counsel, Regulatory Law, to support Johnson & Johnson MedTech. The role is for a regulatory attorney on the MedTech Legal Team, providing strategic legal counsel on a broad range of regulatory and compliance issues in support of the development and commercialization of innovative MedTech products, services, and solutions, including complex capital and Class III devices. The position can be based in Washington, D.C.; Santa Clara, California; New Brunswick, New Jersey; or Raritan, New Jersey. The Senior Counsel advises 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, and partners with legal, quality, regulatory, compliance, privacy, policy, and business colleagues. Travel within the United States is required up to 10% of the time.
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 and the ability to help business partners find creative, compliant solutions to novel issues.
- Effective communication skills and a consultative style, including the ability to interact with senior business leaders and participate on cross-functional teams.
- Positive attitude and ability to work collaboratively with teams, legal colleagues, and business partners at all levels of seniority.
- Ability to work independently in a fast-paced environment with global teams in multiple time zones.
Nice To Haves
- Experience with complex capital, data rights, machine learning, Artificial Intelligence (AI), 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 United States 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 MedTech Legal Team members and Global Legal Organization colleagues around the world.
- 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 the birth, adoption, or foster care of a child.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
