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Years of Experience
ProfileBoston office of a BCG Attorney Search Top Ranked Law Firm seeks FDA/healthcare associate attorney with 4-8 years of experience. The ideal candidate will join the growing FDA regulatory and life sciences compliance practice, which includes full product life cycle counseling on FDA regulatory compliance issues such as product submissions, compliance with labeling and clinical trial requirements, healthcare technology transactions and core compliance issues like fraud and abuse, internal investigations, state licensure, corporate practice of medicine, transparency reporting and reimbursement. Will be involved in litigation or enforcement issues with a regulatory core, such as responding to FDA Warning Letters or other enforcement actions, managing recalls or addressing reimbursement overpayments. Should have strong knowledge base in the business and regulatory aspects of the life science and healthcare technology industry, including digital health, diagnostics, drug, biologic and medical device technologies. Knowledge of health privacy/HIPAA is a plus. Overall interest in a blended FDA and healthcare practice with a life sciences industry and healthy technology/digital health focus is ideal. Strong contract drafting, legal research, and drafting of regulatory submissions is required. Must have an active license to practice law.
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