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Job Function:
Legal & ComplianceJob Sub Function:
Law Business PartnersJob Category:
ProfessionalAll Job Posting Locations:
Danvers, Massachusetts, United States of America, New Brunswick, New Jersey, United States of America, Santa Clara, California, United States of America, Washington, District of Columbia, United States of AmericaJob Description:
We are searching for the best talent to be a Senior Counsel, Regulatory Law, MedTech.
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/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 New Brunswick, New Jersey, Washington, D.C., Santa Clara, California, or Danvers, Massachusetts.
Purpose: 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.
You will be responsible for:
- 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/Requirements:
- Have a J.D. or LL.M. with admission to and good standing with the bar of one state or the District of Columbia.
- 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 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, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
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 CredibilityThe anticipated base pay range for this position is :
$150,000.00 - $258,750.00For Bay Area:
$172,000.00 - $297,850.00Additional 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
Skills Required
- 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 of experience in the medical devices industry (law firm, regulatory agency, and/or in-house)
- Experience advising on U.S. regulatory, compliance, and privacy matters, including advertising and promotion, quality, regulatory strategy, clinical research, and cybersecurity
- Excellent strategic and analytical skills with ability to find creative, compliant solutions
- Effective communicator with a consultative style capable of interacting with senior business leaders and cross-functional teams
- Ability to work independently in a fast-paced environment with global teams
- Experience with data rights, machine learning, Artificial Intelligence (AI), robotics, and Software as a Medical Device
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
