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Corporate Counsel, Digital Healthcare Compliance
Refer job# ZLYR169686
 
Corporate Counsel, Digital Healthcare Compliance Responsibilities: Advise on and manage legal risks relevant to ADI's business with focus on digital healthcare compliance matters including regulatory, compliance, marketing, and litigation. Revise, enhance, and drive implementation of compliance policies, processes, and procedures. This includes, but is not limited to, implementing policies and procedures to comply with federal and state transparency requirements. Perform gap analysis to help ensure that ADI's compliance policies and procedures are effective. Assist with developing and implementation of the compliance training programs for Digital Healthcare group. Monitor and research regulatory, case law, and legislative issues and trends related to digital healthcare compliance. Anticipate changes impacting operations, advise management and recommend preparatory actions. Partner with Legal Operations, IT, and Internal Audit to automate and enhance compliance controls. Sit on the Digital Health Compliance Committee and review the activities of the programs and projects of Digital Healthcare group. Coordinate with Regulatory Affairs managers to ensure compliance with the requirements of regulatory agencies including HHS/OCR, FDA and EMA. Address data privacy issues arising out of Protected Health Information collection, processing, and implementing HIPAA/HITECH complaint procedures. Conduct, and coordinate internal investigations concerning potential violations of policies or law that present compliance and/or legal risk to ADI. Document investigative steps, draft investigation reports, and brief management on investigation outcome. Develop and help implement appropriate corrective actions. Assist in compliance reviews, RBA and Clients' audits and government agencies monitoring activities.

Qualifications: Juris Doctor (J.D.) degree from accredited law school and admitted to at least one State Bar (Massachusetts preferred). Should have 8+ years of legal practice, law firm, and/or in-house counsel. Should have 3+ years of medical/healthcare compliance experience, including advising on medical/digital healthcare compliance issues and implementing policies and procedures for medical/digital healthcare products (i.e. FDA, Sunshine Act, HIPAA, clinical trials, research co-development). Experience analyzing and advising on HIPAA issues. Experience managing outside counsel, including setting and overseeing budgets. Highly proficient in MS Office Suite (Word, Excel, PowerPoint). Demonstrated success in influencing and interacting at all levels of an organization. Ability to establish and develop relationships of trust and confidence. Preferred Qualifications: In-house experience at a multi-national medical device/digital healthcare company. In-house experience for a technology company. Experience working with law enforcement (DOJ or other agencies). Export control compliance experience. Data privacy compliance experience.
 
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