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Manager Fda Consulting Jobs (NOW HIRING)

Alston

FDA Technical Consultant

Washington, DC · On-site +1

Alston & Bird is seeking an experienced FDA consultant to work with the Health Care team's FDA ... Proficient in using quality management systems and documentation tools. * Ability to provide ...

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Manager Fda Consulting information

What are the key skills and qualifications needed to thrive as a Manager in FDA Consulting, and why are they important?

To thrive as a Manager in FDA Consulting, you need a deep understanding of FDA regulations, compliance strategies, and industry best practices, typically supported by a relevant degree and experience in regulatory affairs. Familiarity with regulatory submission systems like eCTD, and certifications such as RAC (Regulatory Affairs Certification), are commonly required. Strong leadership, problem-solving abilities, and excellent communication skills set top performers apart in this role. These competencies ensure clients receive effective guidance through complex regulatory processes, minimizing compliance risks and expediting product approvals.

What does a Manager in FDA consulting do?

A Manager in FDA consulting oversees projects and teams that help clients navigate the regulatory requirements set by the U.S. Food and Drug Administration (FDA). Their responsibilities include advising companies on compliance, preparing submissions, and developing strategies to obtain FDA approvals for products such as drugs, medical devices, and food items. They also ensure clients are up-to-date with changing regulations and help resolve any regulatory issues that may arise. This role requires strong project management skills, deep regulatory knowledge, and the ability to communicate complex requirements to clients.

What is the difference between Manager Fda Consulting vs Regulatory Affairs Specialist?

AspectManager Fda ConsultingRegulatory Affairs Specialist
CredentialsTypically requires a bachelor's or master's in life sciences, with experience in FDA regulationsUsually holds a bachelor's degree in life sciences or related field, with certification preferred
Work EnvironmentConsulting firms, client sites, or remote; project-based workIn-house or pharmaceutical/medical device companies; regulatory departments
Industry UsageCommonly employed in consulting firms advising multiple clientsPrimarily employed within companies managing regulatory submissions

While both roles require knowledge of FDA regulations, a Manager Fda Consulting typically leads consulting projects and advises clients, whereas a Regulatory Affairs Specialist manages regulatory submissions within a company. The roles differ mainly in scope, environment, and responsibilities, but share core regulatory knowledge.

How does a Manager in FDA Consulting typically collaborate with cross-functional teams to ensure regulatory compliance for clients?

As a Manager in FDA Consulting, you'll frequently work alongside experts from regulatory affairs, quality assurance, clinical research, and product development to guide clients through complex compliance challenges. This often involves facilitating meetings, interpreting FDA guidelines, and coordinating the preparation of submission documents. Strong communication skills are essential, as you'll translate regulatory requirements into actionable strategies for diverse teams. Collaboration is key to ensuring all stakeholders are aligned and that client deliverables meet both regulatory and business objectives.
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Manager Fda Consulting jobs near you
Infographic showing various Manager Fda Consulting job openings in the United States as of May 2026, with employment types broken down into 79% Full Time, 14% Part Time, and 7% Contract. Highlights an 93% In-person, and 7% Hybrid job distribution.
Digital Health FDA Consultant (SaMD - AI/Generative AI/LLMs)

Digital Health FDA Consultant (SaMD - AI/Generative AI/LLMs)

Saviance

Boston, MA • Remote

Other

Posted yesterday

Job description

Job Title: Digital Health FDA Consultant (SaMD - AI/Generative AI/LLMs)
Location: Remote (USA or India)
Engagement: Contract (Part-Time)
About the Role
We are seeking an experienced Digital Health FDA Consultant with deep expertise in Software as a Medical Device (SaMD) and hands-on experience guiding AI-driven products through the FDA clearance process. The ideal consultant will have strong knowledge of Generative AI, Large Language Models (LLMs), and AI-enabled disease diagnosis workflows, and can advise our team on regulatory, compliance, safety, and validation requirements.
This role is ideal for someone who has supported early-stage health tech or digital health companies in successfully navigating SaMD regulatory pathways.
Key Responsibilities
  • Provide end-to-end regulatory guidance for FDA SaMD submissions (510(k), De Novo, Pre-Sub, etc.)
  • Develop and review documentation including:
    • SaMD Risk Analysis (ISO 14971)
    • Clinical Evaluation Reports (CER)
    • Software Documentation per FDA and IMDRF
    • Validation/Verification Plans (V&V)
    • Human Factors and Usability documentation
  • Advise on regulatory strategy for AI/ML-enabled medical software, including:
    • Continuous learning algorithms
    • Model transparency, explainability, and bias mitigation
    • Real-world performance monitoring frameworks
  • Guide compliance with:
    • FDA's AI/ML SaMD Action Plan
    • Good Machine Learning Practices (GMLP)
    • 21 CFR Part 820, Part 11, and FDA Digital Health Policies
  • Support development teams by translating regulatory requirements into:
    • Product requirements
    • Model performance metrics
    • Validation/clinical testing strategies
  • Assess and advise on the use of Generative AI and LLMs for disease diagnosis and clinical decision support
  • Prepare teams for FDA interactions and Q-Sub meetings
  • Conduct gap assessments for regulatory readiness and documentation completeness
Required Qualifications
  • 5-10+ years of experience in digital health, FDA regulatory consulting, or medical software compliance
  • Proven experience in FDA clearance for Software as a Medical Device (SaMD)
  • Hands-on experience with AI/ML-based medical devices, including algorithm validation and clinical evidence requirements
  • Familiarity with Generative AI, LLMs, and their application in diagnostics or decision-support tools
  • Strong understanding of:
    • IMDRF SaMD Framework
    • IEC 62304 (software lifecycle)
    • ISO 14971 (risk management)
    • FDA Guidance on Clinical Decision Support (CDS)
  • Demonstrated capability to work with engineering, data science, and clinical teams
  • Excellent communication skills and ability to simplify regulatory concepts for technical teams
Preferred Qualifications
  • Experience with GenAI-enabled clinical decision support or diagnostic models
  • Prior work with health-tech startups or AI-driven digital health products
  • Understanding of HIPAA, PHI handling, and healthcare data governance
  • Knowledge of EU MDR/IVDR (bonus but not required)
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About Saviance

Sourced by ZipRecruiter

Saviance is a modern consulting firm providing a variety of professional services to its clients in the US. We bring twenty three years of experience to the table. Our consultants are qualified experts and extremely talented. We understand the business behind the technology, and work with many of the top Fortune 100 companies and provide innovative, scalable, robust and secure solutions. At the forefront of the Staffing and IT Solutions industry, Saviance is certified by NMSDC as a Tier 1, Minority Business Enterprise (MBE) . We are a self- certified Small Business and self- certified Woman Owned Business committed to maximizing global workforce solutions on behalf of our clients, empowering businesses and talent through applied human intelligence. We are a Diversity Supplier with global reach specializing in a business services blend of talent, technology, and a relentless commitment to customer success. It’s our diversity that’s acts as a core component of our culture, our approach to business, and the opportunities we provide to our clients and our employees.

Industry

It services

Company size

201 - 500 Employees

Headquarters location

East Rutherford, NJ, US

Year founded

1999

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