Co-Founder & EVP of Regulatory Affairs

Company Description

GenomAI is a cutting-edge company that specializes in developing AI software to transform health data into actionable insights. Our mission is to empower physicians to make proactive and faster decisions, and to enable individuals to understand and act on their health information.

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Role Description

We are seeking an experienced physician executive to join GenomAI as Co-Founder & EVP of Regulatory Affairs. This strategic leadership position will be instrumental in securing FDA clearance for our AI-based precision oncology platforms via the 510(k) pathway and potential De Novo classification. The ideal candidate will leverage their clinical, regulatory, and strategic expertise to guide GenomAI through complex regulatory landscapes while contributing to the company's overall vision and growth strategy.

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KEY RESPONSIBILITIES

Regulatory Strategy & Execution (60%)  

• Lead the development and execution of regulatory strategies for FDA clearance  
• Design and oversee clinical validation studies to support 510(k) submissions, with specific focus on substantial equivalence to predicate devices  
• Prepare and review comprehensive regulatory submissions (pre-submissions, 510(k)s, De Novo applications)  
• Serve as primary liaison with FDA, including leading pre-submission meetings and formal interactions  
• Develop regulatory roadmaps for AI/ML-based SaMD products, addressing FDA's evolving framework for AI/ML technologies  
• Establish and maintain quality management systems compliant with FDA requirements for SaMD  
• Monitor and interpret changing regulations relevant to AI in healthcare, genomics, and precision medicine

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Strategic Leadership (25%)  

• Participate in executive leadership decisions as a founding member of the company  
• Align regulatory strategy with business objectives and product development timelines  
• Collaborate with product development, clinical, and data science teams to ensure regulatory considerations are integrated early in development cycles  
• Guide the company's approach to clinical validation studies, including protocol development, site selection, and outcomes assessment  
• Develop strategies for post-market surveillance and continued algorithm validation  
• Represent GenomAI in industry forums and with potential investors on regulatory matters

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Clinical & Medical Affairs (15%)  

• Provide clinical perspective on product development to ensure medical validity  
• Support development of clinical protocols for validation studies  
• Contribute to scientific publications and presentations  
• Engage with key opinion leaders in oncology and precision medicine  
• Assist with developing clinical use cases and value propositions  
• Guide the clinical aspects of marketing and educational materials

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QUALIFICATIONS

Required  

• MD degree from accredited medical school  
• 5+ years of experience in regulatory affairs within digital health, precision medicine, or oncology  
• Demonstrated understanding of FDA regulatory pathways for SaMD, particularly 510(k) and De Novo processes  
• Familiarity with AI/ML-based medical technologies and associated regulatory considerations  
• Knowledge of clinical genomics and molecular diagnostics in oncology  
• Strong understanding of clinical validation study design and execution  
• Experience interacting with FDA on regulatory submissions  
• Exceptional analytical skills and research abilities  
• Outstanding written and verbal communication skills  
• Strategic leadership experience in healthcare technology  

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Preferred  

• Board certification in oncology, pathology, or related specialty  
• Prior experience with successful 510(k) or De Novo clearances for AI/ML-based products  
• Experience with companion diagnostics or clinical decision support software  
• Background in precision oncology and/or genomic medicine  
• Understanding of CMS coverage and reimbursement processes for diagnostic technologies  
• Business development or healthcare venture experience  
• Publication record in relevant clinical or technology fields

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POSITION DETAILS

• Type: Part-time (20-25 hours/week), with flexibility to adjust during critical regulatory phases  
• Location: Remote, with occasional travel to headquarters and regulatory meetings  
• Equity: Competitive equity package commensurate with co-founder status  
• Compensation: Deferred compensation until series A funding is achieved. Bonuses will be provided after achieving regulatory milestones

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WHY JOIN GENOMAI

As a co-founder and executive leader at GenomAI, you will have the opportunity to:  

• Shape the regulatory strategy of an innovative AI healthcare company from its early stages  
• Contribute directly to improving cancer care through cutting-edge technology  
• Work with a passionate team of experts in AI and precision medicine  
• Build significant equity value in a high-growth potential company  
• Make a lasting impact on the regulatory approach for AI in precision medicine  
• Balance meaningful work with the flexibility of a part-time, remote position

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TO APPLY

Please submit your CV/resume, a cover letter detailing your relevant experience in regulatory affairs and precision medicine, and a brief statement on your vision for the regulatory pathway for AI-powered analysis tools to support@genom-ai.com