The Director, Digital Health Privacy & Compliance Counsel will be responsible for leading the Privacy & Compliance program at OPH. The ideal candidate will have experience advising medical device, digital health, and A.I. clients on the application of healthcare privacy and regulatory laws to their business. The position will report to the OPH Executive Director, Deputy General Counsel.

• Assist in developing, implementing, and maintaining a comprehensive healthcare Privacy & Compliance program for OPH
• Oversee the development and dissemination of relevant privacy and compliance Policies, SOPs, and Training to OPH employees
• Serve as the subject matter expert on international, federal, and state data privacy and security laws and regulations, including GDPR, HIPAA, CCPA, and other such requirements
• Provide clear and practical guidance on relevant federal and state laws and regulations, including, but not limited to, the FDCA, FCA, AKS, and FTCA
• Stay abreast of on emerging legislative, regulatory, and industry privacy trends, proactively educating relevant stakeholders on such trends and ensuring business is prepared to respond
• Advise digital health, data, and A.I. teams on patient, consumer, and other privacy laws and regulations applicable to OPH’s core businesses
• Partner with relevant stakeholders to manage regulatory inquiries, government investigations, administrative actions, and internal investigations
• Manage periodic privacy and compliance risk assessments, internal audits, and ongoing monitoring
• Manage the process for DPIAs, Third-Party Due Diligence, and other privacy and compliance assessments
• Draft and negotiate data licenses, data use agreements, and other relevant agreements, as well as advise on technical implementation and compliance with privacy and data security terms
• Help optimize priority processes, including Incident Response, Data Subject Request Management, etc.
• Manage OPH’s incident management system (Speak-up line)
• Coordinate with Global and Regional Otsuka Group Companies Privacy Leads to identify opportunities to drive enhancements across the businesses

• J.D. admitted to the bar in good standing
• 7+ years of counseling and advising medical device and healthcare clients on compliance with healthcare privacy and regulatory laws
• Experience in the MedTech or Digital Health industry or at a law firm serving such clients, with the ability to bring a foundational understanding of the industry and other related functional areas
• Experience implementing compliance programs, specifically in the areas of compliance risk assessment, compliance auditing and monitoring, and third-party risk management, as well as policies, procedures and training
• Demonstrated strong commitment to compliance and ethics, excellent judgment, a strong backbone, and comfortable providing candid and unpopular guidance to senior leaders
• Excellent communication and collaboration skills, with the ability to develop strong relationships and influence stakeholders across the organization
• Demonstrated leadership experience
• Strong problem-solving skills, with an ability to creatively identify and implement solutions
• Excellent analytical skills and the ability to appropriately communicate complex compliance and legal concepts and their relevant potential risks clearly to non-legal stakeholders for consideration
• Ability to travel up to 25%