SaMD Regulatory FDA Consultant
Contract: 26 weeks
Apply NowBased in the United States
Available for a part-time engagement (approximately 20–30% FTE)
The Role
- Provide strategic regulatory guidance for U.S. FDA submissions
- Review and support the preparation of 510(k) dossiers and associated technical documentation
- Identify regulatory risks and recommend mitigation strategies
- Support software validation and regulatory documentation activities
- Interact with internal development, clinical, quality, and software teams
- Contribute to FDA pre-submission and submission planning activities
- Support responses to FDA requests, deficiency letters, and regulatory inquiries
Requirements
- Demonstrated success in preparing, reviewing, and submitting FDA 510(k) applications for in vitro diagnostic (IVD) devices
- Strong knowledge of U.S. FDA regulations applicable to IVDs, including 21 CFR Part 809 and relevant FDA guidance documents
- Experience interacting directly with FDA reviewers and managing regulatory communication throughout the submission process
- Demonstrated ability to effectively negotiate disagreements with the FDA in the submissions process.
- Proven ability to develop regulatory strategies for new product introductions, product modifications, and market access activities
Technical & Regulatory Expertise
- Experience with analytical and clinical performance validation of IVD devices
- Strong understanding of Design Control requirements and regulatory documentation
- Experience with Software Validation and Software Documentation for FDA submissions
- Familiarity with FDA expectations regarding Software as a Medical Device (SaMD), embedded software, and cybersecurity documentation
- Ability to review and provide regulatory input on software development, verification, and validation activities
Desired background
- Experience with flow cytometry-based IVD devices and related regulatory submissions would be a plus
- Experience with laboratory-developed tests (LDTs), companion diagnostics, or complex assay platforms
- Knowledge of IVDR (EU 2017/746) and global regulatory frameworks is an advantage
- Familiarity with quality systems compliant with FDA QSR and ISO 13485
- Proven track record of successful FDA 510(k) clearances for IVD products
- Strong scientific and technical understanding of diagnostic technologies
- Pragmatic, solution-oriented, and able to work independently
- Excellent written and verbal communication skills
- Strong stakeholder management and consulting skills
Nice-to-Have Experience
- Flow cytometry assays/platforms
- Gastroenterology, immunology, allergy, or biomarker-based diagnostics
How to Apply
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