State Licensed Medical Device Analyst

Job Summary

A company is looking for a Medical Device Safety Analyst.

Key Responsibilities

• Conduct medical reviews, including in-house review of Case Report Forms (CRFs) and quality assurance of data listings
• Manage activities associated with clinical studies, including regional contract CRAs and budget organization
• Provide medical support for adverse event reporting and communication, including documentation preparation for regulatory authorities

Required Qualifications, Training, and Education

• Bachelor's degree in Nursing or higher with a minimum of 3-4 years' experience in the medical device industry
• Minimum of 5 years direct patient care experience as a Registered Nurse preferred
• Expert understanding of global Medical Device regulations such as FDA and EU-MDR
• Sound knowledge of device risk management and associated documentation
• Proficiency in computer applications, including Windows, Word, and Excel