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Medical Device Risk Management Advisor (Part-Time, Remote)

FocusKPI Inc.
Remote

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Job Details

Part-time

Qualifications

Usability testing
Feature validation testing
Conducting user feedback sessions
Good documentation practices (GDP)
Mid-level
Analysis skills
Quality assurance in testing
Quality risk management
Compliance documentation
Design controls
Biomedical regulatory compliance
FMEA
Product quality assurance
Usability feedback collection
Hazard analysis
Regulatory compliance analysis
Prototypes

Full Job Description

We are building an AI-powered platform to support medical device risk management and regulatory documentation (including ISO 14971 and design controls), and are looking for a few professionals to serve as ongoing product feedback advisors.

This is a flexible, part-time opportunity for experienced professionals who can periodically test new features, review workflows, and provide practical feedback based on real-world medical device and regulatory experience. Your input will directly shape how the product supports day-to-day work in regulated environments.

What You’ll Do

Test new features and prototypes periodically
Provide feedback on usability and regulatory alignment
Review risk management and documentation workflows
Suggest improvements based on real industry practice
Join occasional 30–45 minute feedback sessions

Time Commitment

Flexible, ongoing engagement
Approximately 1–2 hours per week or biweekly
Fully remote

Preferred Background

Medical device regulatory affairs or quality assurance
Experience with ISO 14971 risk management
Design controls / DHF documentation
510(k), De Novo, or PMA experience is a plus
Risk management file, FMEA, or hazard analysis experience

Consultants and industry professionals are welcome.

How to Apply

If you’re interested, please complete this short screening form so we can better understand your background:
https://forms.gle/jgj1ZN2jtAGGAbYQA

We’ll follow up with selected candidates to schedule an initial session and discuss next steps.

NOTICE: Please be aware of fraudulent emails regarding job postings, job offers and fake checks. FocusKPI's recruiting team will strictly reach out via @focuskpi.com email domain. If you have received fraudulent emails now or in the past, please report it to https://reportfraud.ftc.gov/ .
The domain @focuskpijobs.com is fraudulent and not related to FocusKPI. Please do not not reply or communicate to anyone with @focuskpijobs.com.

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Pyramid Consulting, Inc. jobs

Medical Device Risk Management Advisor (Part-Time, Remote)

Manager, Learning and Evaluation-Philanthropy

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Risk Specialist (contract)

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Paramedic Wheaton

IONM Technologist

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Configuration Management Specialist , Job Posting # 148

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IONM Technologist

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