Senior Counsel, Regulatory Law, MedTech

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 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

• 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.