Compliance Systems Analyst I (REMOTE)
REMOTE, IN 00000 US
**salary will commensurate with experience**
-Evaluate complaints and determine if a medical device report (MDR) is needed per FDA regulations 21 CFR 803 and Roche procedures.
-Where a report is not needed provide a detailed and compliant rationale
-Where a report is needed, complete the MDR form in the case handling IT tool and submit for review and approval.
Minimum 3 years pathology/hospital laboratory experience or 3 years working as a healthcare professional (nurse, physician assistant) required
-Attention to detail
-Critical thinking skills a must
-Excellent writing skills
-Ability to work with minimal supervision
-Familiarity with Roche products is a plus
-Knowledge of FDA Regulations, including 21 CFR 803 is a plus
?*CO/NYC candidates might not be considered
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.