Rohan Mahajan

• Managed end-to-end complaint lifecycle (intake → triage → investigation → reportability → closure) across US FDA (eMDR), EU MDR (MIR), and ROW requirements using structured decision trees and global SOPs.
• Executed regulatory submissions (eMDR / EU MDR MIR) with consistent on-time delivery; ensured documentation accuracy and audit readiness.
• Contributed to QMS operations (ISO 13485 alignment): handled deviations, CAPA, and change controls; supported root cause analysis (RCA) and effectiveness checks.
• Developed/updated SOPs and work instructions; delivered training sessions to teams on regulatory updates, complaint handling workflows, and IMDRF coding.
• Performed trend analysis, signal detection, and error analysis using Excel/Power BI; built and validated dashboards/KPIs to monitor PMS performance and quality metrics.
• Collaborated with R&D/Engineering, Clinical, and Regulatory stakeholders to investigate failure modes, assess clinical impact, and support ISO 14971 risk management activities.
• Facilitated cross-functional meetings and maintained MOMs, driving action tracking and timely closure of CAPA/deviation items.
• Proposed and implemented process improvements (Lean mindset)—standardized trackers, streamlined workflows, and reduced cycle times for complaint closure and reporting.
• Mentored team members on end-to-end PMS processes, regulatory decision trees, and quality documentation practices.

• Processed and evaluated 3000+ global medical device complaints, ensuring high accuracy, SLA adherence, and compliance with US FDA (eMDR) and EU MDR (MIR) reporting requirements.
• Performed reportability assessments (NR/RM) using structured decision trees aligned with global regulatory frameworks and internal SOPs.
• Applied IMDRF coding and clinical data interpretation to standardize complaint classification and support regulatory reporting accuracy.
• Conducted trend analysis and signal detection on complaint datasets, identifying recurring failure modes and supporting risk evaluation activities.
• Collaborated with Regulatory Affairs, Quality, and global stakeholders to ensure consistent documentation, compliance, and timely submission of regulatory reports.
• Supported data-driven decision-making by generating insights using Excel (advanced functions, pivot analysis) and structured datasets.
• Maintained data integrity, audit readiness, and documentation quality, ensuring alignment with global compliance standards.
• Participated in process improvement initiatives, contributing to enhanced complaint handling efficiency and reduced turnaround time (TAT).
• Assisted in training and knowledge-sharing sessions for team members on complaint handling workflows, regulatory requirements, and data interpretation.

• Managed QMS activities including deviations, CAPA, and change control, ensuring compliance with GMP and global regulatory standards.
• Performed root cause analysis (RCA) and supported CAPA implementation, contributing to continuous quality improvement and compliance effectiveness.
• Reviewed batch manufacturing records (BMRs), quality documentation, and data integrity practices, ensuring accuracy, completeness, and audit readiness.
• Collaborated with Production, Quality Control, and Regulatory teams to resolve quality issues and maintain compliance across manufacturing operations.
• Supported internal audits and inspection readiness, ensuring adherence to SOPs, GMP guidelines, and documentation standards.
• Monitored quality trends and deviations, identifying recurring issues and supporting preventive action strategies.
• Ensured compliance in sterile injectable manufacturing processes, with focus on documentation, contamination control, and quality assurance practices.
• Participated in process improvement initiatives, enhancing workflow efficiency and strengthening QMS effectiveness.

• Performed aseptic compounding of chemotherapy (oncology) and sterile preparations in ISO 5 cleanroom environments, ensuring strict adherence to aseptic techniques and contamination control standards.
• Followed EU GMP, MHRA, and US FDA-aligned guidelines for sterile manufacturing, documentation, and quality compliance, maintaining high standards of safety and traceability.
• Executed dose calculations, preparation, labeling, and batch documentation for patient-specific formulations, ensuring accuracy and data integrity.
• Conducted environmental monitoring and supported sterility assurance activities, contributing to cleanroom compliance and product quality.
• Analyzed quality trends and deviations, supporting CAPA-driven improvements and providing data-based insights to enhance production efficiency and minimize defects.
• Contributed to process efficiency initiatives by supporting lean workflow improvements and identifying opportunities to optimize operations, reduce manual effort, and maintain regulatory compliance.

• Delivered direct patient care to elderly residents, supporting activities of daily living (ADLs) including mobility, hygiene, nutrition, and medication assistance under supervision.
• Monitored and recorded vital signs and clinical observations, promptly escalating changes to nursing staff to support patient safety and care planning.
• Maintained accurate patient records and documentation, ensuring confidentiality and compliance with healthcare standards and protocols.
• Collaborated with multidisciplinary teams (nurses, caregivers, clinicians) to provide coordinated, patient-centered care.
• Followed strict infection control and hygiene protocols, including PPE usage and environmental sanitation practices.
• Supported patient well-being and communication, assisting with emotional support and engagement to improve quality of care outcomes.

• Analyzed patient records to ensure accurate and compliant coding according to ICD-10 and CPT guidelines.
• Reviewed medical documentation for completeness, identifying discrepancies and resolving coding errors efficiently.
• Collaborated with healthcare providers to clarify diagnoses and procedures, enhancing coding accuracy and patient care.
• Trained new staff on coding policies, procedures, and software tools, promoting consistency in coding practices.