Medical Document Control Specialist

14 hours ago


Richmond, California, United States Kaléo Full time

Company Overview

Kaléo is a pioneering company in the medical device industry, committed to developing life-transforming products that make a tangible impact. With secured contracts with the U.S. government, we are seeking an experienced Documentation Specialist - Development Engineering to join our team.

Salary and Benefits

We offer a competitive salary of $120,000 per year, plus benefits that include health insurance, 401(k) matching, and a remote work environment.

Job Description

The successful candidate will have a critical role in managing and executing the Design History File (DHF) documentation for new drug/device combination products. This includes creating and maintaining support documentation, coordinating documentation with internal and external partners, and ensuring compliance with regulatory requirements.

Required Skills and Qualifications

  • Bachelor's degree in an engineering discipline
  • 3+ years of experience in the medical device industry, including product development and test method development and execution
  • Experience editing design controls and supporting Design History File creation/management for medical devices
  • Ability to travel overnight up to 15%

Benefits

We value diversity, equity, and inclusion and strive to create an inclusive work environment where everyone feels welcome and supported. Our hybrid culture offers flexibility in choosing your work location and schedule, with clear objectives and milestones.

Others

This is an exciting opportunity to work on life-transforming products while operating within a deadline-focused environment. If you are a detail-oriented engineer with product development experience in the medical device industry, please submit your application for consideration.



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