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

FocusKPI Inc.Boston, MA

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Overview

Schedule

Flexible-schedule

Part-time

Career level

Senior-level

Remote

Benefits

Flexible/Unlimited PTO

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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FAQs About Medical Device Risk Management Advisor (Part-Time, Remote) Jobs at FocusKPI Inc.

What is the work location for this position at FocusKPI Inc.?

This job at FocusKPI Inc. is located in Boston, MA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at FocusKPI Inc.?

Employer has not shared pay details for this role.

What employment applies to this position at FocusKPI Inc.?

FocusKPI Inc. lists this position under the following employment categories:

Flexible-schedule
Part-time

What experience level is required for this role at FocusKPI Inc.?

FocusKPI Inc. is looking for a candidate with "Senior-level" experience level.

Does FocusKPI Inc. allow remote work for this role?

Yes, this position at FocusKPI Inc. supports remote work, giving candidates the flexibility to work outside the primary office location.

What is the process to apply for this position at FocusKPI Inc.?

You can apply for this role at FocusKPI Inc. either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.