Senior Counsel, Regulatory Law, MedTech

6090-Johnson & Johnson Services Inc. Legal Entity; New Brunswick (NJ); On-site; USD 154,000 - 266,000; Full time

Benefits offered by this job

Pension plan

401(k) Savings plan

Significant paid time off (vacation/s;

Parental Leave

Job summary

Johnson & Johnson seeks a Senior Counsel, Regulatory Law, MedTech to support its MedTech Legal Team within the Global Legal Organization (GLO). The role provides strategic legal counsel on regulatory and compliance issues across the device lifecycle, including complex capital devices and AI/ML systems.

The position can be based in Washington, D.C., Santa Clara, CA, New Brunswick, NJ, or Raritan, NJ. Strong collaboration, communication with senior leaders, and global teamwork are essential.

Qualifications

• J.D. or LL.M. with admission to and good standing with the bar of one state or the District of Columbia.
• At least 7 years in the medical devices industry, law firm, regulator, or in-house.
• Experience advising on U.S. regulatory, compliance, privacy, advertising, quality, and cybersecurity.
• Experience with complex capital, data rights, AI/ML, robotics, and Software as a Medical Device is preferred.

Responsibilities

• Advise on regulatory strategy, clinical research, premarket clearance, and product launches.
• Guide quality and regulatory teams in interactions with regulators and inspections.
• Supervise paralegal review of US promotional materials in cross-functional teams.
• Advise on interactions with providers, payors, and officials under fraud and abuse laws.
• Engage in external regulatory and policy initiatives with trade associations.
• Collaborate with GLO colleagues worldwide; partner with compliance and privacy teams.
• Travel within the United States up to 10% of the time.

Skills

AI Judgement Integration

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

Education

J.D. or LL.M. with bar admission (state/DC)

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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:

New Brunswick, New Jersey, United States of America, Raritan, 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 for Senior Counsel, Regulatory Law, MedTech. 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 Washington, D.C., Santa Clara, California, New Brunswick, New Jersey, or Raritan, New Jersey. 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.

• 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:

• 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.
• Experience with complex capital, 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, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource. #LI-Hybrid

Required Skills:

Preferred Skills: AI Judgement Integration, 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 : $154,000.00 - $265,650.00 For Bay Area: $177,000.00 - $305,900.00

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: https://www.careers.jnj.com/employee-benefits At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com/. Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you. Do Not Sell or Share My Personal Information Limit the Use of My Personal Information