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

FocusKPI

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profile Job Location:

Boston, NH - USA

profile Monthly Salary: Not Disclosed
Posted on: Yesterday
Vacancies: 1 Vacancy

Job Summary

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 Youll 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 3045 minute feedback sessions

Time Commitment

  • Flexible ongoing engagement
  • Approximately 12 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 youre interested please complete this short screening form so we can better understand your background:
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. FocusKPIs recruiting team will strictly reach out via @ email domain. If you have received fraudulent emails now or in the past please report it to .
The domain @ is fraudulent and not related to FocusKPI. Please do not not reply or communicate to anyone with @.


Required Experience:

Junior IC

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 profe...
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About Company

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FocusKPI offers custom marketing analytics solutions and specialized data science support to fit your timeline and budget. Among our areas of expertise are: personalization solutions, measurement (MMM & MTA), and customer sentiment analysis.

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