anushka khadilkar

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Capstone Regulatory Affairs & Quality Specialist

Regulatory Affairs & Quality Specialist at Sole who developed FDA 510(k) assessment tools and a document control system.

United StatesCapstone Regulatory Affairs & Quality Specialist at Sole

Experience

Capstone Regulatory Affairs & Quality Specialist
Conducted 510(k) feasibility assessment and developed Q-Sub templates and predicate comparison trackers per FDA/PreSTAR guidance. Established document control system per 21 CFR 820.40 and ISO 13485:2016, including Master Document Register and Document Control SOP.
510(K)FDA RegulationsQ SubmissionDocument Control21 CFR 820ISO 13485QMSSOPs
Regulatory Affairs & Quality Specialist
Performed regulatory assessments for change controls and managed product complaints, including adverse event reports. Conducted labeling reviews, developed standardized templates, and supported post-market surveillance and quality system management review.
Regulatory AffairsChange Control21 CFR 820ISO 13485Complaint HandlingLabelingPost Market SurveillanceMAUDEMDRQuality System Management
QA Associate
Reviewed and approved laboratory reports for pharmaceutical products, ensuring accuracy and compliance with SOPs. Supported investigations of laboratory deviations and participated in root cause analysis and CAPA activities.
Quality AssuranceLab ReportingSOPsGMPRoot Cause AnalysisCAPAData IntegrityDocumentation Review

Education

Northeastern University
Pursuing a Master of Science in Regulatory Affairs with a perfect GPA of 4.00/4.00, expected to complete in July 2026.
Pursuing a Master of Science in Regulatory Affairs with a perfect GPA of 4.00/4.00, expected to complete in July 2026.
Poona College of Pharmacy, Bharati Vidyapeeth
Earned a Bachelor of Pharmacy in Pharmaceutical Sciences, completing the program in June 2023.
Earned a Bachelor of Pharmacy in Pharmaceutical Sciences, completing the program in June 2023.
Duke Medicine
Completed the ORAQ Regulatory Affairs certification from Duke Medicine.

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Experience

Capstone Regulatory Affairs & Quality Specialist

Conducted 510(k) feasibility assessment and developed Q-Sub templates and predicate comparison trackers per FDA/PreSTAR guidance. Established document control system per 21 CFR 820.40 and ISO 13485:2016, including Master Document Register and Document Control SOP.

510(K)FDA RegulationsQ SubmissionDocument Control21 CFR 820ISO 13485QMSSOPs

Regulatory Affairs & Quality Specialist

Performed regulatory assessments for change controls and managed product complaints, including adverse event reports. Conducted labeling reviews, developed standardized templates, and supported post-market surveillance and quality system management review.

Regulatory AffairsChange Control21 CFR 820ISO 13485Complaint HandlingLabelingPost Market SurveillanceMAUDEMDRQuality System Management

QA Associate

Reviewed and approved laboratory reports for pharmaceutical products, ensuring accuracy and compliance with SOPs. Supported investigations of laboratory deviations and participated in root cause analysis and CAPA activities.

Quality AssuranceLab ReportingSOPsGMPRoot Cause AnalysisCAPAData IntegrityDocumentation Review

Education

Northeastern University

Pursuing a Master of Science in Regulatory Affairs with a perfect GPA of 4.00/4.00, expected to complete in July 2026.

Poona College of Pharmacy, Bharati Vidyapeeth

Earned a Bachelor of Pharmacy in Pharmaceutical Sciences, completing the program in June 2023.

Duke Medicine

Completed the ORAQ Regulatory Affairs certification from Duke Medicine.