Senior Counsel, Regulatory Law
The Johnson & Johnson Law Department is recruiting for a Senior Counsel, Regulatory Law to support the Johnson & Johnson Medical Devices Companies. This position will be based at Johnson & Johnson World Headquarters in New Brunswick, NJ or at Johnson & Johnson facilities in Milpitas, CA, Redwood City, CA, Santa Clara, CA. and Washington, DC.
In this role you will:
• Provide specialized legal counsel and strategic advice on a wide range of regulatory and compliance issues to support the development of innovative med tech products, services and solutions, including digital health and robotically-assisted surgical devices.
• Advise 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, social media, post-market surveillance, and quality system compliance.
• Guide quality and regulatory teams on interactions with regulators, hospitals, and physicians and provide legal support during regulatory inspections and discussions of potential field actions.
• Review and supervise paralegal review of United States promotional and educational materials as part of a cross-functional team.
• Advise 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.
• Engage in external regulatory and policy initiatives with trade associations and Johnson & Johnson policy teams.
• Be a member of the Global Regulatory Legal Team and collaborate with Johnson & Johnson Law Department colleagues around the world.
• Partner with the Johnson & Johnson Health Care Compliance and Privacy Organizations to assess risk, develop policies, and conduct internal training.
• Travel within the United States up to 10% of the time.
The successful candidate will:
• Have a J.D. or LL.M. with admission to and good standing with the bar of one state or the District of Columbia.
• Have at least 7 years of experience in the life sciences 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 and compliance matters and medical device regulation, including data rights, protected health information (PHI), and privacy and cybersecurity issues.
• Preferably have experience and an understanding of the role of big data, machine learning, and Artificial Intelligence (AI) in driving business/clinical insights information systems, data management, website and mobile app development, and Software as a Medical Device.
• 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 who is comfortable 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.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Learn more here
Job posted: 2021-07-18