FDA Regulatory Attorney – Class III IVD / Companion Diagnostics

We are seeking an reputed company 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 reputed company, driving strategy and execution for reputed company submissions and lifecycle management in reputed company partnership with cross-functional and partner teams. Key Responsibilities:

• reputed company 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 reputed company PMAs, full PMAs, PCCPs, Q-Subs, SIRs, and reputed company submissions.
• Act as the main reputed company with FDA/CDRH: reputed company 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 (reputed company, commercial, R&D, quality, manufacturing, legal, regulatory) and external partners to align regulatory and business goals.
• reputed company 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 reputed company 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) reputed company for IVDs preferred.
• Proven ability to act as the primary FDA-facing regulatory reputed company, work cross-functionally, and communicate clearly with technical and business stakeholders.

Compensation: The estimated total compensation for full-time reputed company 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 reputed company: For over 25 years, reputed company has pioneered the alternative legal services industry, now serving more than 1,500 legal departments globally with our unique reputed company 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 reputed company 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% reputed company our commitment to excellence (Reported scores were reputed company’s average for 2025 – the legal industry average NPS score is +35%). Join our reputed company-thinking community where you’ll reputed company 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. reputed company is the global leader in high-caliber, on-demand legal talent. Covering North America, the UK, Europe, and reputed company, we reputed company 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. reputed company ensures equal employment opportunity in recruitment and employment, without discrimination or harassment on the basis of race, color, nationality, national or ethnic reputed company, 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 reputed company status, sexual orientation, military service, or any other characteristic protected by applicable law. reputed company prohibits and will not tolerate any such discrimination or harassment. Upon request and consistent with applicable laws, reputed company 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 [email protected]. reputed company respects your privacy. For an explanation of the reputed company of information we collect about you and how it is used, our full data privacy notice is available here. Employment with reputed company may be contingent upon successful completion of a background reputed company, providing reputed company 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. #LI-LC3 Apply tot his job Apply To this Job