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IIA/HHE Specialist

Job

Sira Consulting, an Inc 5000 company

Bothell, WA (In Person)

Full-Time

Posted 4 days ago (Updated 1 day ago) • Actively hiring

Expires 6/22/2026

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Job Description

IIA/HHE Specialist at Sira Consulting, an Inc 5000 company IIA/HHE Specialist at Sira Consulting, an Inc 5000 company in Bothell, Washington Posted in about 1 hour ago.
Type:
full-time
Job Description:
Job Description:
Experienced medical device QARA professionals with strong expertise in Issue Impact Assessment (IIA) and Health Hazard Evaluation (HHE), capable of making clinical risk-based decisions supporting global regulatory compliance and patient safety Skill requirement: Strong understanding of:
ISO 14971
risk management process Medical device lifecycle Complaint handling workflows Experience in: Writing
IIA & HHE
documents Clinical risk interpretation
FDA:
21 CFR 803 (MDR)
QMSR / 820 EU
MDR vigilance requirements
Understanding of:
Reportability thresholds Safety signal evaluation Clinical / Medical Understanding (Critical for HHE) Ability to: Interpret clinical scenarios Assess patient harm realistically
Preferred:
Exposure to radiology spcefically Ultrasound is a Plus. Others are also welcome.

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