Senior Counsel, Regulatory Law, MedTech

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

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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.

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 colle...