Compliance Analyst ( Medical Device )
KKR Consulting partners with businesses to solve challenges, streamline processes, and achieve lasting success. We specialize in providing tailored consulting services across Aerospace, Medical Devices, Automotive, Pharmaceuticals, and Biotechnology industries, helping clients drive innovation, enhance operations, and achieve sustainable growth.
- *Job Title:**
Compliance Analyst
- *Location:**
Remote (USA)
- *Description:**
Due to continued 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 within 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 when appropriate.
- Test returned units from reported complaints and ensure investigations are thorough and well-documented.
- Close 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
- Vision insurance
- Dental insurance
- 401(k)
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