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Regulatory Affairs Associate/Specialist; Medical Devices strong Clinical Science capabi
Job in
Milpitas, Santa Clara County, California, 95035, USA
Listed on 2026-02-05
Listing for:
Tiposi
Full Time
position Listed on 2026-02-05
Job specializations:
-
Healthcare
Medical Science, Medical Science Liaison
Job Description & How to Apply Below
- Lead the preparation, strategy, and submission of FDA regulatory applications for medical devices, including Breakthrough Device Designation, De Novo submissions, and other FDA pathways as appropriate.
- Develop end-to-end regulatory strategies that integrate clinical evidence, benefit‑risk considerations, and device performance data into FDA‑ready submissions.
- Design and support clinical validation strategies that demonstrate safety, effectiveness, sensitivity, and specificity in alignment with FDA expectations.
- Author and contribute to clinical and scientific sections of FDA submissions, including clinical evaluation reports, literature reviews, and safety and effectiveness documentation.
- Interpret and analyze clinical data from validation studies and translate findings into clear regulatory narratives suitable for FDA review.
- Serve as a regulatory representative in FDA interactions, including pre‑submission meetings and formal FDA meetings, capable of addressing both regulatory and clinical science questions.
- Conduct regulatory and clinical gap analyses to identify potential risks or deficiencies and proactively propose mitigation strategies.
- Collaborate closely with clinical development, quality assurance, engineering, and medical teams to ensure alignment on regulatory and clinical strategy.
- Interface with clinical experts, including neurologists and emergency medicine physicians, to define appropriate clinical endpoints and validation methodologies.
- Support responses to FDA inquiries during review, including those related to clinical evidence, study design, and data interpretation.
- Ensure compliance with applicable FDA regulations, including 21 CFR Part 820, IDE requirements, and Good Clinical Practice (GCP) standards.
- Minimum of 5 years of experience working at the FDA in a regulatory role, with direct involvement in medical device regulation.
- Advanced degree (PhD or MD) in neuroscience, biomedical engineering, or related field with stroke/neurology expertise.
- Demonstrated hands‑on experience preparing and submitting FDA regulatory applications and participating in FDA meetings.
- Strong ability to operate at a clinical scientist level, including interpretation of clinical data and development of clinical rationale to support FDA submissions.
- Experience supporting clinical studies for medical device regulatory submissions (e.g., De Novo, PMA, or 510(k)).
- Track record working with FDA regulations (21 CFR Part 820, IDE requirements, clinical trial protocols)
Position Requirements
10+ Years
work experience
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