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Compliance Systems Analyst I (REMOTE)

REMOTE, IN 00000

Posted: 01/19/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 533746 Is job remote?: Yes Country: United States

Job Description

Target PR Range: 20-30
**salary will commensurate with experience**

Responsibilities include:
-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
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