Medical Device Writer Manager

3 weeks ago


Schaumburg, Illinois, United States BISCO, Inc. Full time

BISCO, Inc. is seeking an experienced Clinical Reports Manager to lead our regulatory affairs efforts in Schaumburg, IL. As a key member of our team, you will play a critical role in ensuring compliance with global Clinical Regulatory strategies and advancing our business objectives.

Key Responsibilities

The Clinical Reports Manager will be responsible for:

  • Developing and implementing clinical regulatory strategies for new and legacy devices
  • Authoring and maintaining Clinical Evaluation Reports and Summary of Safety and Clinical Performance (SSCPs)
  • Reviewing General Safety and Performance Requirements and Essential Principles in design and development
  • Interpreting results and preparing product applications by evaluating clinical, scientific, risk data, and literature
  • Conducting and overseeing literature searches for state of the art, clinical research, and post market surveillance
  • Participating in planning, authoring, and maintenance of post market surveillance reports, Periodic Safety Update Reports, and Post Market Clinical Follow-up reports
  • Monitoring clinical regulatory requirements and trends as part of the Regulatory Intelligence process
Why Join Us?

We offer a competitive salary range of $87,000-$102,000 per year, commensurate with experience, as well as a comprehensive benefits package, including medical, dental, and vision insurance, HRA and FSA, short and long-term disability, life insurance, PTO, 401(k) profit-sharing with match, and potential year-end bonuses.

Our company culture values Respectful-Professional-Humble-Considerate, Positive-Friendly-Inclusive-Curious, and Team Player-Helpful-Cooperative-Flexible. We strive to create a positive work environment that fosters collaboration and growth.


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