FDA法规律师 - III类IVD/伴随诊断
FDA Regulatory Attorney – Class III IVD / Companion Diagnostics
我们正在寻找一位经验丰富的FDA法规律师，具备在III类PMA体外诊断（IVD）和伴随诊断产品方面的深入实践经验，为我们的客户——一家财富500强临床实验室工作。该职位将作为主要的FDA法规负责人，与跨职能团队和合作伙伴紧密合作，推动复杂提交和生命周期管理的战略与执行。
主要职责：
- 领导III类PMA IVD和伴随诊断产品的FDA法规战略与执行，包括生命周期PMA规划和批准后变更。
- 负责模块化PMA、完整PMA、PCCP、Q-Sub、SIR及相关提交的策略、起草和管理。
- 作为与FDA/CDRH的主要对接人：主持会议、协商立场，并起草对FDA补充信息请求的回复。
- 提供关于审批前和审批后要求（质量体系、风险管理、MDR、标签和其他上市后义务）的建议。
- 支持510(k)监管IVD的产品分类和上市前策略，包括Q-Sub准备。
- 与跨职能团队（业务发展、商业、研发、质量、制造、法律、法规）和外部合作伙伴合作，协调法规与业务目标。
- 开发并提供关于医疗器械和IVD FDA法规的培训，包括审批/许可和执法主题。
任职要求：
- 法学博士（J.D.）学位，并在至少一个美国司法管辖区持有执业律师执照。
- 在医疗器械或诊断公司拥有至少五年内部工作经验者优先。
- 直接负责III类PMA IVD和/或伴随诊断提交（策略、起草和与FDA的互动）。
- 最近有模块化PMA、FDA Q-Sub、PCCP、SIR及生命周期PMA策略的实际操作经验。
- 熟悉FDA针对III类PMA设备、IVD和伴随诊断的法规和指南；熟悉IVD的510(k)路径者优先。
- 具备作为主要FDA对接法规负责人的实际能力，能够跨职能协作，并能清晰地与技术和业务利益相关者沟通。
薪酬：
全职Axiom律师职位的预估总薪酬为每年104,500至325,000美元，非律师职位的预估总薪酬为每年71,250至309,750美元。薪酬决策基于多种因素，包括但不限于经验、技能、认证、地点和业务需求。员工可能享有其他福利。
查看英文原文
We are seeking an experienced FDA Regulatory Attorney with deep, hands-on expertise in Class III PMA in vitro diagnostic (IVD) and companion diagnostic products to work with our client, a Fortune 500 clinical laboratory. This person will serve as the primary FDA-facing regulatory lead, driving strategy and execution for complex submissions and lifecycle management in close partnership with cross-functional and partner teams.
Key Responsibilities:
- Lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics, including lifecycle PMA planning and post-approval changes.
- Own strategy, drafting, and management of Modular PMAs, full PMAs, PCCPs, Q-Subs, SIRs, and related submissions.
- Act as the main interface with FDA/CDRH: lead meetings, negotiate positions, and draft responses to FDA requests for additional information.
- Advise on pre- and post-approval requirements (quality systems, risk management, MDRs, labeling, and other post-market obligations).
- Support product classification and premarket strategies for 510(k)-regulated IVDs, including Q-Sub preparation.
- Partner with cross-functional teams (BD, commercial, R&D, quality, manufacturing, legal, regulatory) and external partners to align regulatory and business goals.
- Develop and deliver training on FDA regulation of medical devices and IVDs, including approvals/clearances and enforcement topics.
Qualifications:
- J.D. and active license to practice law in at least one U.S. jurisdiction.
- At least five years of in-house experience at a medical device or diagnostics company is preferred.
- Direct ownership of Class III PMA IVD and/or companion diagnostic submissions (strategy, drafting, and FDA interaction).
- Recent, hands-on experience with Modular PMAs, FDA Q-Subs, PCCPs, SIRs, and lifecycle PMA strategy.
- Strong knowledge of FDA regulations and guidance for Class III PMA devices, IVDs, and companion diagnostics; familiarity with 510(k) pathways for IVDs preferred.
- Proven ability to act as the primary FDA-facing regulatory lead, work cross-functionally, and communicate clearly with technical and business stakeholders.
Compensation:
The estimated total compensation for full-time Axiom attorney roles is $104,500-325,000 per year and for non-attorney roles is $71,250-309,750 per year.Compensation decisions are based on various factors, including, but not limited to, experience, skills, certifications, location, and business needs. Employees may be eligible for additional benefits, including health, dental, and vision insurance; paid holidays and PTO; flexible work arrangements; and professional development opportunities and tools.
About Axiom:
For over 25 years, Axiom has pioneered the alternative legal services industry, now serving more than 1,500 legal departments globally with our unique blend of world-class legal talent and advanced AI tools, delivering innovative solutions ranging from that combine top-tier talent with cutting-edge technology. We tackle complex legal matters across 12 practice areas for clients ranging from Fortune 100 to SMBs, empowering our legal professionals to engage in meaningful work that advances their careers. Our Talent NPS score of +71% and our Client NPS score of +64% highlight our commitment to excellence (Reported scores were Axiom’s average for 2025 – the legal industry average NPS score is +35%). Join our forward-thinking community where you’ll keep your career dynamic and multi-faceted, be part of a company that values agility, collaboration, and excellence, and love both the law and your life.
Learn more about life at Axiom.
Axiom is the global leader in high-caliber, on-demand legal talent. Covering North America, the UK, Europe, and APAC, we enable legal departments to drive efficiency and growth and meet the demands of today’s business landscape with best in class alterative legal services.
Diversity is core to our values and we are proud to be an equal opportunity employer. Axiom ensures equal employment opportunity in recruitment and employment, without discrimination or harassment on the basis of race, color, nationality, national or ethnic origin, religious creed or belief, political opinion, sex, gender, gender identity, gender identity status, pregnancy or maternity, age, disability, alienage or citizenship status, marital (or civil or other partnership recognized by law) status, genetic predisposition or carrier status, sexual orientation, military service, or any other characteristic protected by applicable law. Axiom prohibits and will not tolerate any such discrimination or harassment.
Upon request and consistent with applicable laws, Axiom will provide reasonable accommodations for individuals with disabilities who require accommodations to participate in each stage of the recruitment process. To request an accommodation, please contact .
Axiom respects your privacy. For an explanation of the kind of information we collect about you and how it is used, our full data privacy notice is available here.
Employment with Axiom may be contingent upon successful completion of a background check, providing proof of identity, and possessing the necessary legal authorization to work. Pursuant to the San Francisco Fair Chance Ordinance, NY Fair Chance Act, and Los Angeles Fair Chance Initiative, we will consider for employment qualified applicants with arrest and conviction records.
Originally posted on Himalayas