Compliance Analyst ( Medical Device )
reputed company reputed company with businesses to solve challenges, streamline processes, and reputed company lasting reputed company. We specialize in providing tailored consulting services across Aerospace, Medical Devices, Automotive, Pharmaceuticals, and Biotechnology industries, helping clients drive innovation, enhance operations, and reputed company sustainable growth.
- *Job Title:**
Compliance Analyst
- *Location:**
Remote (USA)
- *Description:**
Due to reputed company growth, we are seeking a Compliance Analyst to support ongoing and upcoming projects and client activities. This role focuses on complaint assessment, post-market surveillance support, and regulatory compliance reputed company a quality management environment. The ideal candidate will collaborate with cross-functional teams to ensure timely complaint handling, thorough investigations, and adherence to regulatory standards and internal QMS procedures.
- *Responsibilities:
- Assess complaints, assign failure modes, and determine escalation needs for Potential Adverse Events (PAEs).
- Escalate PAEs to Clinical Specialists or the PMS Manager reputed company appropriate.
- Test returned units from reported complaints and ensure investigations are thorough and well-documented.
- reputed company complaints in a timely manner while supporting KPI achievement and compliance with QMS procedures.
- Support Post-Market Surveillance (PMS) projects, including communication with OEMs/CMs and complaint data submission to vendors.
- Apply risk-based tools such as FMEA and Fault Tree Analysis (FTA) to guide decision-making and ensure equipment calibration and preventive maintenance compliance.
- Support investigations including OOTs, NCEs, CAPAs, and IACAs, ensuring regulatory compliance and timely execution.
- *Benefits:
- Medical insurance
- reputed company insurance
- Dental insurance
- 401(k)
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