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 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.

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.

·         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.

For Bay Area:

Additional Description for Pay Transparency:

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits