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RA(FDA) Specialist

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Position

RA(FDA) Specialist

About Our Client

builds AI solutions that improve clinical decision-making and hospital efficiency through predictive analytics. The company is expanding its U.S. regulatory and compliance activities for medical AI products (SaMD), with a focus on FDA clearance and real-world data integration.

Job Summary

seeking an experienced FDA regulatory consultant to support SaMD regulatory strategy and submissions, particularly involving AI/ML-based predictive models and EHR-derived clinical data. This part-time role will collaborate with both the U.S. subsidiary and Korean HQ to shape regulatory pathways, documentation, and interactions with the FDA.

Job Description

• - Provide regulatory guidance on SaMD classification, strategy, and submission pathways (e.g., 510(k), De Novo).
• - Review and advise on FDA documentation including Q-sub packages, risk management files, clinical evidence plans, and validation documentation.
• - Support the preparation of regulatory submissions related to EHR data usage, model training/validation datasets, and real-world evidence.
• - Evaluate existing development and quality documentation for FDA readiness.
• - Offer consultation on software documentation, labeling, cybersecurity, and human factors
• requirements.
• - Advise on regulatory expectations for AI/ML-based devices, including drift monitoring and model
• update frameworks.
• - Participate in periodic meetings with HQ teams to ensure regulatory alignment.

Qualifications

• - 5+ years of regulatory experience with medical devices, ideally including SaMD or digital health submissions.
• - Prior FDA submission experience (510(k), De Novo, Q-Sub) strongly required.
• - Strong understanding of AI/ML SaMD regulatory expectations and EHR data governance.
• - Familiarity with IEC 62304, ISO 14971, and FDA SaMD guidance documents.
• - Experience working with global teams preferred.
• - Excellent communication and documentation-review skills.
• - Ability to work independently on a part-time consulting basis.

What's On Offer

• - Medical Insurance
• - 401k
• - Accident insurance
• - COBRA
• Vacations:
• - 20 days for each full calendar year worked.
• - If the work period is less than a full calendar year, 20/12 days for each full month worked.
• - Plus 1 additional vacation day for each 2 full calendar years worked.
• National holidays: 10 days.

Apply online or feel free to contact us directly for more information about the opportunity. Due to the high volume of applicant, we regret to inform that only shortlisted candidates will be notified. Thank you for your understanding.


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