Senior Counsel, Regulatory Law, MedTech

Role Summary

Senior Counsel, Regulatory Law, MedTech provides strategic legal counsel on regulatory and compliance issues to support the development and commercialization of MedTech products and solutions. The role is part of the Global Regulatory Legal Team within Johnson & Johnson's Global Legal Organization, located in New Brunswick, NJ or Washington, DC. The position collaborates across quality, compliance, and policy teams to enable safe, innovative, and compliant MedTech offerings.

Responsibilities

• 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

• 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.
• 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. FDA regulatory, compliance, and privacy matters, including advertising and promotion, quality, regulatory strategy, clinical research, and privacy issues.
• Experience with the role of data, machine learning, and Artificial Intelligence (AI) in driving, data management, website and mobile app development, 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.