Rohan Mahajan
MDR RA QA Analyst (Business Analyst)
Pune,MH
Summary
Business Analyst | Healthcare & Life Sciences Consulting | Medical Devices RA QA
Healthcare technology professional with 4+ years of international and cross-functional experience across the medical device and pharmaceutical industries. Seeking a role in Post-Market Surveillance (Medical Device Complaint Handling), Regulatory Affairs, or Quality Assurance, where I can leverage my expertise in US FDA compliance, eMDR reporting, EU MDR, QMS, and data analytics to improve regulatory outcomes, ensure product quality, and uphold patient safety by proactively identifying and mitigating device risks, malfunctions, or hazards.
Overview
4
4
years of professional experience
Work History
Business Analyst Healthcare & Regulatory Strategy
Genpact
12.2023 - Current
- Led process transformation initiatives, optimizing complaint handling workflows, ensuring faster resolution and improved compliance tracking.
- Partnered with cross-functional teams & data analysts to develop real-time dashboards, enabling leadership to make data-driven risk decisions.
- Managed process improvement & risk assessment projects, reducing incident resolution time by 30% through Root Cause Analysis (RCA) & CAPA optimization.
- Developed strategic insights & reporting frameworks, helping senior management enhance regulatory decision-making and reduce compliance risks.
- Implemented change control impact assessments, aligning regulatory processes with business goals & operational efficiency improvements.
- Successfully delivered high-priority projects ahead of deadlines, ensuring client expectations were met with high-quality execution.
Quality Assurance Officer
Puniska Injectables Fresenius Kabi
09.2023 - 12.2023
- Conducted quality control inspections to ensure compliance with industry standards. Deviations Change Controls. CAPA Impacted activities.
- Developed and maintained quality assurance documentation and procedures.
- Collaborated with cross-functional teams to address quality-related issues effectively.
- Analyzed product defects and implemented corrective actions to enhance product quality.
Compounding Technician
Quantum Pharmaceuticals/Target Healthcare
10.2022 - 06.2023
- Led process efficiency initiatives, identifying cost-saving opportunities that improved sterile manufacturing operations & reduced compliance overhead.
- Advised leadership on risk assessment & automation strategies, ensuring regulatory compliance while reducing manual workload by 25%.
- Implemented lean process improvements, optimizing resource utilization and reducing operational costs by 20% through CAPA-driven workflow enhancements.
- Analyzed quality trends & deviations, providing data-driven recommendations that minimized defects & improved production efficiency.
Healthcare Assistant
Gavin Astor House Nursing home
10.2021 - 08.2022
- Assisted in managing daily operations of healthcare facility to ensure smooth workflow
- Coordinated patient admissions, discharges, and transfers to enhance patient experience
- Supported budget management by tracking expenses and processing invoices efficiently
- Collaborated with medical staff to streamline communication and improve service delivery
Education
MBA - Information Technology
Bharati Vidyapeeth University
Pune, India12.2025
No Degree - Data Analytics
Coding Ninja
Delhi, India03.2025
PGDM - Pharmaceutical Science
University of Greenwich
London, UK09-2022
Bachelor's - Pharmacy
K.B.C North Maharashtra University
Shirpur, India06.2020
Skills
- Business & Strategy Consulting
✅ Business Analytics & Insights – Process Optimization, Strategic Advisory, Data-Driven Decision-Making
✅ Healthcare & Life Sciences Consulting – Risk Management, Market Strategy, Compliance Optimization
✅ Stakeholder & Client Engagement – Cross-Functional Collaboration, Business Strategy Alignment
✅ Regulatory Strategy – US FDA, EU MDR, ISO 13485, ISO 14971, GMP, Post-Market Surveillance
✅ Risk & Compliance Management – CAPA, Root Cause Analysis (RCA), Change Control, Impact Assessments
✅ Audit & Quality Optimization – Risk Assessment, FMEA, Compliance Audits, Deviation Management
✅ Decision Analytics & Reporting – Business Intelligence, Dashboarding, KPI Tracking
✅ Process Automation & AI – Generative AI, Lean Six Sigma, Workflow Automation, Process Optimization
✅ Advanced Analytics Tools – Power BI, Tableau, SQL, Python (Basic), Excel
Certification
- Lean Six Sigma Green Belt – CAPA & Process Optimization
- ISO 13485 & ISO 14971 – Medical Device Quality & Risk Management
- Generative AI Certification – AI in Business & Responsible AI
- Agile Practices – Regulatory Compliance & Risk Management
- Python for Data Analysis – Automating Healthcare Compliance
- Data Analytics with SQL & Power BI – Data-Driven Decision Making
Affiliations
- Led regulatory analytics & compliance tracking, improving efficiency in risk assessment & decision-making.
- Collaborated with data & analytics teams to develop real-time reporting dashboards for leadership.
- Managed CAPA investigations & Root Cause Analysis, improving incident resolution efficiency by 30%.
- Enhanced post-market surveillance processes, ensuring data-driven risk mitigation strategies.
Additional Information
CERTIFICATIONS & INDUSTRY KNOWLEDGE
- Regulatory & Compliance Expertise – US FDA, EU MDR, ISO 13485, ISO 14971, Risk Management
- Business & Process Optimization – Lean Six Sigma, CAPA, Root Cause Analysis (RCA), Change Control
- Decision Analytics & Reporting – Partnering with Data Teams for Insights, Process Automation, BI & Dashboarding
Languages
English
Advanced (C1)
Hindi
Bilingual or Proficient (C2)
Marathi
Bilingual or Proficient (C2)
Timeline
Business Analyst Healthcare & Regulatory Strategy
Genpact
12.2023 - Current
Quality Assurance Officer
Puniska Injectables Fresenius Kabi
09.2023 - 12.2023
Compounding Technician
Quantum Pharmaceuticals/Target Healthcare
10.2022 - 06.2023
Healthcare Assistant
Gavin Astor House Nursing home
10.2021 - 08.2022
MBA - Information Technology
Bharati Vidyapeeth University
No Degree - Data Analytics
Coding Ninja
PGDM - Pharmaceutical Science
University of Greenwich
Bachelor's - Pharmacy
K.B.C North Maharashtra University