Senior Counsel, Regulatory Law, MedTech

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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

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, Washington, District of Columbia, United States of America

Job Description:

Johnson & Johnson is searching for the best talent for Senior Counsel, Regulatory Law, MedTech to join our Global Legal Organization located in New Brunswick, NJ or Washington, D.C.

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

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. 

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 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.
 

Qualifications / Requirements:


* A J.D.

or LL.M.

with admission ...