Bhavya Muttamsetty
About Me
Master of Science in Regulatory Affairs Graduate, Northeastern University | Deep Dive into US FDA, EU MDR Regulations | Drug Safety Knowledge
Location
Arizona City, AZ
Education
N
Northeastern University
January 2023 - July 2024
degree
Master's
major
Public Health
coursework
Regulatory Affairs
V
Vignan Institute of Pharmaceutical Technology
Work Experience
X
Xellar Biosystems
Capstone Project Medical Device Quality and Regulatory Compliance Specialist
Boston, MA, United States, 02297
March 2024 - June 2024
company
Xellar Biosystems
title
Capstone Project Medical Device Quality and Regulatory Compliance Specialist
overview
• Developed and executed a comprehensive regulatory strategy for Xellar OC-Plex. Implemented a Quality Management System (QMS),
ensuring FDA compliance by aligning with both HQ procedures and cGMP standards, which accelerated commercial readiness by 20%.
• Collaborated with cross-functional teams to implement GMP-compliant quality systems, reducing procedural errors by 15% and
maintaining high standards of quality assurance.
H
HHT Pharma
Internship Trainee
Hyderabad, TG, India
November 2021 - November 2022
D
Deepam Hospitals
Internship Trainee
Chennai, TN, India
August 2021 - October 2021
Skills
Administration of Computer SystemsAdobe AcrobatAuditing SkillsBiochemistryBiotechnologyBrand ManagementBrochure DesignBusiness Process ImprovementCarrying out AssessmentsCase StudiesChromatographyClinical ResearchCommunication SkillsCorrective and Preventive ActionCost ReductionCustomer ServiceData IntegrityData QualityData SecurityDissolutionElectronic Common Technical DocumentEthicsGood Clinical PracticesHealth CareHealth Insurance Portability and Accountability Act ComplianceIch GuidelinesInfectious DiseasesInnovationISO 13485Iso StandardsJurisprudenceKnowledge of ImmunizationKnowledge of Packaging and ProcessingKnowledge of Standards ComplianceLabelingLandscapingManufacturingMarketingMass ProductionMaterial Safety Data SheetsMedical MaterialsMedical PrivacyMicrobiologyMicrosoft OfficeMicrosoft ProjectMicrosoft SharePointModel ValidationOccupational Safety and HealthOrganic ChemistryPassionatePatient SafetyPharmaceutical EngineeringPharmaceutical RegulationsPharmaceuticalsPharmacologyPlexProblem SolvingProduct DesignProduct Information ManagementProject ManagementPublishing SkillsPulmonary Tuberculosis (Professional Expertise)Quality ManagementRecruitmentRegulatory AffairsRegulatory ComplianceRemote MonitoringRisk ManagementSafety PrinciplesSciencesSimulationsSix Sigma MethodologySmartsheetSpectrophotometryStrategic ManagementStrategic ThinkingStreamlineTableau (Software)Team WorkingTitle 21 of the Code of Federal Regulations