Legal Counsel
简介：通过纳克资本寻求经验丰富的法律顾问，至少拥有8年的法律实践，专业于美国医疗保健和医学行业。在这个角色中，你将担任高级管理层和运营团队的战略法律顾问。导航复杂的医疗保健法规，谈判高风险商业协议，减轻企业风险。理想候选人具有深入的学科知识在联邦和州卫生保健法律，医疗设备或临床操作监管，数据隐私和美国医疗生态系统内的商业合约。主要责任：· 监管与遵守策略：咨询内部团队遵守美国关键的医疗保健法规，包括 HIPAA/HITECH,反病例条款 (AKS),斯塔克法律，虚假索赔法案 (FCA) 和 FDA 规定 （如适用）. ·商业和卫生服务合同：拟定，审查和谈判复杂协议，包括临床试验协议 (CTAs),商业合作伙伴协议 (BAAs),管理护理 /提供商合约，SaaS/软件许可证，供应商协议以及战略合作伙伴关系。·数据隐私与安全：密切合作与合规和 IT 安全，以确保所有产品功能，数据共享管道和患者互动符合 HIPAA,州隐私法 （例如 CCPA/CPRA）和新兴的健康数据规则。·公司和风险管理：在产品推出，营销举措和临床整合中确定运营和法律风险，提供平衡业务增长与法律遵守的实用解决方案。·争端解决 &调查：处理诉讼前纠纷，监督监管查询，并根据需要支持内部合规调查。·外部顾问管理：协调与监管文件，知识产权或诉讼事务的外部专业律师确保成本效益高质量的法律支持。要求资格和要求：· 法学博士学位 (JD) ·美国认可大学获得法学博士学位是好但不是必需品。·在至少一个美国州积极招生律师。· 8年以上执业经验，具有国内医疗设备，生物技术，数字健康或医疗服务公司或在国家法律事务所中接受的卫生保健核心实践组内有着显著经验。· 在美国执业经历8年以上；
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Description:
FDNA through Nacre Capital is seeking an experienced Legal Counsel with at least 8 years of legal practice, specializing in the United States healthcare and medical industries. In this role, you will serve as a strategic legal advisor to senior management and operational teams, navigating complex healthcare regulations, negotiating high-stakes commercial agreements, and mitigating enterprise risk.
The ideal candidate possesses deep subject-matter expertise in federal and state healthcare laws, medical device or clinical operations regulation, data privacy, and commercial contracting within the US medical ecosystem.
Key Responsibilities:
- Regulatory & Compliance Strategy: Advise internal teams on compliance with key US healthcare statutes, including HIPAA/HITECH, the Anti-Kickback Statute (AKS), the Stark Law, the False Claims Act (FCA), and FDA regulations (where applicable).
- Commercial & Healthcare Contracting: Draft, review, and negotiate complex agreements, including Clinical Trial Agreements (CTAs), Business Associate Agreements (BAAs), Managed Care / Provider contracts, SaaS/Software licenses, vendor vendor agreements, and strategic partnerships.
- Data Privacy & Security: Work closely with Compliance and IT Security to ensure all product features, data-sharing pipelines, and patient interactions align with HIPAA, state privacy laws (e.g., CCPA/CPRA), and emerging health data rules.
- Corporate & Risk Management: Identify operational and legal risks across product launches, marketing initiatives, and clinical integrations, providing pragmatic solutions that balance business growth with legal compliance.
- Dispute Resolution & Investigations: Handle pre-litigation disputes, oversee regulatory inquiries, and support internal compliance investigations as needed.
- External Counsel Management: Coordinate with outside specialized counsel on regulatory filings, intellectual property, or litigation matters to ensure cost-effective, high-quality legal support.
Requirements
Qualifications & Requirements:
- A Juris Doctor (JD) degree
- A JD from an accredited US university is good to have but not a must.
- Active bar admission in good standing in at least one US state.
- 8+ years of practicing law, with significant experience either in-house at a US medical device, biotech, digital health, or healthcare delivery company, or within a recognized healthcare practice group at a national law firm.
- Expertise navigating core US healthcare frameworks (HIPAA, Anti-Kickback, Stark Law, FDA guidelines).
- Proven track record drafting and negotiating complex commercial agreements in the medical or life sciences sector.
- Exceptional communication skills with the ability to translate legal concepts into actionable advice for cross-functional business partners.
- Fluency in English is a MUST
Note: CV/Resumé and Cover Letter submissions MUST be in English.
Originally posted on Himalayas