• Redesigned 100+ labels with UDI data matrix for compliance with ISO 15223, IEC 60601, and FDA standards and validated label art proofs using UDI Reader.• Executed shelf-life validation for caps, documented the validation plan and results improving product reliability by 15%.• Supported ISO 13485 and INMETRO 384 recertification audits by preparing key documentation and assisting audit teams, achieving adherence to medical device regulatory standards.• Assisted in upgrading IEC 60601-1 reports from edition 3.1 to 3.2 and developed comprehensive risk management files to enhance risk management activities.• Conducted product accuracy tests, ensuring IEC 60601 & 62353 conformity for MDR certification across European markets.• Re-evaluated products and supplier qualifications, updating TDs to meet RoHS, REACH, and CA Prop 65 regulations.• Prepared, reviewed, and processed ECOs & TCOs to reflect changes in manufacturing procedures and technical documents.Ongoing Collaborative Project |Exergen Corporation and Northeastern University• Managing MDR submission process for products, including regulatory, technical, and clinical documentation to ensure adherence to EU MDR.• Leading global IFU and label updates, integrating UDI standards and new notified body/CE marking requirements.• Revising company’s quality system procedures to align with FDA’s QMSR, ISO 13485, and MDSAP audit criteria.

• Provided 24/7 support in the Residential Safety Office.• Assisted residents and parents with inquiries and concerns.• Managed and updated special access lists for authorized individuals.• Promptly reported security breaches and emergencies to public safety.• Developed strong communication and customer service skills.• Maintained composure in high-stress situations.• Committed to upholding safety and security standards.

• Developed 25+ SOPs, test methods, and result reports ensuring QC documentation compliance with laboratory requirements and industry standards by 30%.• Formulated over 150 samples, reagents, buffers, and references for HPLC, Spectrophotometers, and Gas chromatography during instrumental analysis of drugs and cosmetic products while following GLP.• Registered and managed sample data entry, accurately recording raw data and results in an analytical test data sheet.

• Compiled regulatory documentation for extended, delayed, and immediate-release pellets by coordinating with QA and manufacturing departments accelerating MAA and CTD preparation.• Utilized EDMS to organize MAA documents, create a workflow to review CTDs, track the status of regulatory submissions, and generate reports on submission progress.• Assessed inspection readiness and data integrity through internal audits, communicated scientific concepts to internal and external stakeholders, and implemented regulatory compliance programs.• Monitored CAPA progress, assisted in developing and executing CAPA plans, leading to a 20% reduction in recurring issues.