Associate/Senior Associate: FDA/Regulatory

Job Description

At Rubrum Advising, our mission is to help clients advance transformative care through integrated clinical, regulatory, and commercial strategies and solutions, accelerating adoption so people receive better care, sooner. Our work stems from a relentless focus on patients, driven by a team that knows how to ensure new technologies, therapies, and solutions support real-world use and long-term adoption. 

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Reporting to the Principal of the FDA Regulatory Practice, the Associate/Senior Associate, FDA Regulatory serves as a key contributor to the delivery of high-quality regulatory consulting engagements for Rubrum's clients. This is a highly analytical role requiring strong research, technical writing, and organizational skills to help drive regulatory strategies and submissions for a diverse portfolio of medical technologies, including medical devices, diagnostics, digital health technologies, and combination products. The ideal candidate will have experience conducting regulatory research, drafting regulatory documentation, and managing project workstreams and timelines. Title and level (Associate or Senior Associate) will be determined based on experience. 

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The role sits at the intersection of regulatory science, clinical evidence, and product innovation and is ideal for a driven, detail-oriented professional who enjoys solving regulatory challenges, interpreting evolving requirements, and partnering with innovative medical technology companies. It requires the ability to synthesize scientific, clinical, and regulatory information into clear, well-organized deliverables. The Associate/Senior Associate works closely with members of Rubrum's Regulatory, Market Access, Reimbursement, Solutions, and Policy teams to help clients navigate regulatory pathways, generate evidence that supports successful submissions, and accelerate the adoption of innovative medical technologies. 

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Key Responsibilities  

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Research & Analysis  

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• Conduct regulatory landscape and pathway analyses, including research on product classification, predicate and comparable devices, and FDA databases and precedents, to identify risks and opportunities for client products. 
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• Perform primary and secondary research, including reviews of regulations, guidance documents, scientific and clinical literature, and competitive products; synthesize findings into clear, actionable insights. 
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• Evaluate scientific, clinical, and technical evidence to support regulatory strategy development and submission planning. 
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• Monitor and interpret evolving regulations, guidance documents, and agency expectations, and help translate them into practical implications for clients and internal teams. 
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Regulatory Strategy & Technical Writing  

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• Support the development of regulatory strategies for medical devices, diagnostics, digital health technologies, and combination products across the product lifecycle. 
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• Draft and contribute to regulatory deliverables, including regulatory strategies, gap assessments, submission plans, regulatory analyses, and technical documentation. 
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• Support the preparation of premarket submissions and agency interactions (e.g., 510(k), De Novo, PMA, IDE, Pre-Submissions), including section drafting, document compilation, and quality checks. 
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• Help ensure client deliverables are technically accurate, well-organized, and meet the firm's standards for quality and excellence. 
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Client Support & Stakeholder Engagement  

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• Support client meetings and FDA interactions, including preparation of briefing materials and agendas, note-taking, and synthesis of key takeaways and next steps. 
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• Prepare client-ready materials, including presentations, reports, and meeting summaries. 
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• Serve as a day-to-day contact for assigned client workstreams, building trusted relationships through responsive, high-quality support. 
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Project Management  

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• Manage day-to-day execution of client projects, including workplans, timelines, milestones, and deliverable tracking across multiple concurrent engagements. 
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• Coordinate internal resources and communications to ensure timely, high-quality deliverables, and proactively flag project risks to senior team members. 
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Qualifications & Skills  

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• Bachelor's degree required in a scientific or technical discipline, such as biology, chemistry, biochemistry, biomedical engineering, biotechnology, pharmacology, life sciences, or a related field. Advanced degree (e.g., MS, MPH, PhD, PharmD) or JD is preferred. 
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• 2–5 years of relevant experience in regulatory affairs, regulatory consulting, clinical or quality functions, or the medical technology industry, supporting medical devices, diagnostics, digital health technologies, or combination products. 
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• Working knowledge of U.S. FDA regulatory pathways and requirements, including premarket submissions (e.g., 510(k), De Novo, PMA, IDE) and post-market regulatory activities. Familiarity with international regulatory frameworks (e.g., EU MDR/IVDR, Health Canada, TGA, UKCA) is a plus. 
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• Strong research and analytical skills, with demonstrated ability to gather, synthesize, and translate complex scientific, clinical, and regulatory information into clear recommendations. 
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• Excellent technical writing skills, with the ability to produce clear, concise, and client-ready deliverables, including regulatory assessments, reports, presentations, and submission documentation. 
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• Proven project management and organizational skills, including managing workplans, timelines, and deliverables across multiple concurrent projects with strong attention to detail. 
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• Understanding of, or strong interest in, how regulatory strategy intersects with clinical evidence generation, quality systems, reimbursement, market access, and commercialization planning. 
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• Genuine enthusiasm for medical technology, including emerging devices, diagnostics, AI-enabled technologies, and digital health solutions, and curiosity about how innovative products navigate regulatory pathways to reach patients. 
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• Collaborative team player who builds strong internal and external relationships; hands-on, results-oriented, and comfortable operating at both strategic and tactical levels. 
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• Self-motivated, adaptable, and comfortable working in a fast-paced, remote, client service environment; ability to work East Coast (Eastern Time) business hours is required. 
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• Willingness to travel, as needed, to support client engagements, conferences, and business development activities (approximately 5–10%). 
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