Pushkala K

About Pushkala K

Professional SummaryHealthcare & Medical Devices professional with strong experience in Clinical Evaluation, regulatory documentation, and compliance under EU MDR and MEDDEV 2.7/1 Rev 4 guidelines. Currently expanding expertise into Artificial Intelligence & Machine Learning to bridge clinical domain knowledge with data-driven innovation in healthcare. Clinical Evaluation & Regulatory ExpertiseWith 6 years of experience in Medical Devices, I specialize in:• Drafting and reviewing Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Post-Market Clinical Follow-Up Plans (PMCFP), and Post-Market Clinical Evaluation Reports (PMCFER)• Conducting systematic literature reviews and clinical data appraisal• Performing risk-benefit analysis and clinical data gap assessment• Ensuring compliance with EU MDR and MEDDEV 2.7/1 Rev 4• Supporting regulatory submissions through structured clinical evidence documentation• Performing quality checks on regulatory deliverables prior to client submission• Ensuring strict adherence to Good Documentation Practices (GDP)• Collaborating cross-functionally with Regulatory, Quality, and R&D teams• Contributing to post-market surveillance and clinical data monitoring activitiesThis experience has strengthened my analytical thinking, structured documentation skills, and evidence-based decision-making capabilities. Transition into AI & Machine LearningTo expand beyond traditional clinical analysis, I am currently pursuing a Post Graduate Program in Artificial Intelligence & Machine Learning at Great Lakes Institute of Management, offered in collaboration with The University of Texas at Austin – McCombs School of Business (September 2025 – September 2026).Through this program, I am building strong technical foundations in:• Exploratory Data Analysis (EDA)• Classification & Regression modeling• Decision Trees & Ensemble Learning• Bagging & Boosting (Random Forest, Gradient Boosting)• Model evaluation using Precision, Recall, F1-score & ROC-AUC• Feature engineering & handling class imbalance• Customer segmentation & predictive analyticsCurrently advancing into:• Deep Neural Networks• Backpropagation & Optimization• CNNs & RNNs• Natural Language Processing (NLP)• Generative AI & Large Language Models• Prompt EngineeringI am interested in roles at the intersection of Healthcare, Medical Devices, and Artificial Intelligence.

Experience

1. Senior Technical Lead

   HCLTech

   Oct 2025 — Present · Hyderabad, IN

   Leading end-to-end clinical evaluation strategy and regulatory documentation for Class medical devices under EU MDR 2017/745• Driving scientific and regulatory oversight of CER, PMCFER, SSCP, and benefit-risk documentation• Designing advanced systematic literature review frameworks and evidence appraisal methodologies across multiple therapeutic areas• Serving as primary escalation point for Notified Body queries and regulatory audits, ensuring timely resolution and compliance readiness• Governing quality assurance processes, performing high-level scientific reviews to ensure accuracy, consistency, and regulatory alignment• Managing multi-project portfolios with strict adherence to timelines, risk mitigation, and stakeholder expectations• Providing technical leadership and mentoring to cross-functional teams, strengthening regulatory and scientific capability• Collaborating with global regulatory, quality, and R&D teams to align clinical evidence strategy with submission objectives• Driving process optimization initiatives to improve documentation efficiency and compliance robustness

Education

• The University of Texas at Austin

  Post Graduate Program, Artificial Intelligence and Machine Learning

• Manipal Academy of Higher Education

  Masters in pharmacy, Pharmacology

  2014 — 2016

• CMR College of pharmacy

  B. Pharamacy, Pharmacy

Skills

• Research
• Customer Service
• Public Speaking
• Project Management
• Microsoft Office
• Leadership
• Microsoft Excel
• Powerpoint
• Management
• Microsoft Word