Medical Device Writer Manager
3 weeks ago
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 ResponsibilitiesThe 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
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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Clinical Reports Manager Position
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