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
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