Raksha Ray

Associate Consultant

Kolkata, West Bengal, India1 yr 5 mos experience

Most Likely To SwitchAI Enabled

Key Highlights

Expert in Medical Device Regulatory Affairs and Quality Management.
Hands-on experience with ISO compliance and eQMS platforms.
Building AI/ML applications for healthcare risk assessment.

Stackforce AI infers this person is a Biomedical Science and Engineering professional with expertise in Regulatory Affairs and AI applications in healthcare.

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Skills

Core Skills

Regulatory AffairsQuality Management SystemsArtificial IntelligenceFormulation ResearchPharmacy

Other Skills

QMSeQMSISO 13485ISO 14971MDR 2017/745CAPARisk ManagementCybersecurity RiskData ScienceAIDeep LearningPilot BatchTechnical DocumentationLiterature ReviewsHospital Pharmacy

About

I am a Biomedical Science and Engineering professional with an M.Tech in Medical Devices and Diagnostics from IIT Guwahati and a B.Pharm degree (CGPA: 8.8). I bring a strong combination of regulatory compliance expertise, quality management systems knowledge, and emerging AI/ML skills to the healthcare and medical device industry. I currently work in the Medical Device Regulatory Affairs and Quality Management (QMS) domain, with hands-on experience in ISO 13485 compliance, EU MDR alignment, internal audits, CAPA management, risk management (ISO 14971), design and development documentation, traceability matrices, SOP lifecycle management, and audit readiness activities. I have worked extensively with eQMS platforms, collaborating with development and engineering teams to ensure accurate, compliant, and inspection-ready documentation. In parallel, I am building practical expertise in Artificial Intelligence and Machine Learning applications for healthcare and life sciences. I have completed formal training in AI & Drug Discovery and use Python for data analysis, feature engineering, and basic machine learning workflows. My interests include applying AI/ML to medical device risk assessment, clinical and post-market data analysis, regulatory intelligence, predictive quality analytics, and automation of QMS processes bridging technology with compliance to improve efficiency and patient safety.

Experience

Easyq solutions

Regulatory & QMS Specialist

Jul 2025 – Present · 9 mos · Remote

I am a QMS and Regulatory Affairs Specialist with experience in quality compliance, regulatory documentation, and cybersecurity risk management for regulated environments.
I work with ISO 13485, ISO 14971, MDR 2017/745, and support end-to-end QMS activities including SOPs, CAPA, Risk Management Files, DHF/DHR, traceability, and eQMS document control. I also have hands-on knowledge of cybersecurity risk assessment, including CVSS score calculation for vulnerability severity and impact evaluation.
I follow a risk-based, compliance-driven approach to help organizations build robust, audit-ready, and secure quality systems, particularly in medical device and digital health domains.

QMSeQMSISO 13485ISO 14971MDR 2017/745CAPA+4

Topia life sciences

AI Data Science Intern

Oct 2024 – Mar 2025 · 5 mos · Remote

Data processing using Neurokit2 tool and preparing deep learning model using lstm transformer

Data ScienceAIArtificial Intelligence

Sp accure labs private limited

Trainee: Formulation Research and Development

Feb 2022 – Oct 2022 · 8 mos · Hyderabad, Telangana, India · On-site

In my position within the Formulation Research and Development department, I play a pivotal role in the creation and enhancement of pharmaceutical products. This entails conducting in-depth literature reviews, formulating pilot batches, maintaining rigorous documentation, and developing a wide range of dosage form, such as tablets, capsules, injectables, suspensions, and emulsions. My primary objective is to innovate and refine these formulations to meet the highest standards of effectiveness and safety. This role blends elements of research, hands-on formulation work, and meticulous documentation, all contributing to the ongoing progress of pharmaceutical product development.🧪💊📋🔬

Pilot BatchTechnical DocumentationFormulation Research

Calcutta national medical college

Pharmacist

Nov 2021 – Dec 2021 · 1 mo · Kolkata, West Bengal, India · On-site

In my role within the Pharmacy department, I am dedicated to ensuring the safe and efficient provision of essential healthcare services. My responsibilities encompass various critical functions, including precise drug dispensing, meticulous documentation, and the efficient management of medicine stocks. Additionally, I oversee the essential oxygen cylinder department, ensuring a constant supply of this life-saving resource. My passion lies in contributing to the well-being of patients and the smooth operation of healthcare facilities, making a positive impact every day.

Hospital PharmacyPharmacy PracticePharmacy