Rachana Kankapurkar

Regulatory Specialist @ QRx Partners

About

Dedicated Regulatory and Quality professional navigating the intricacies of regulations, submission processes, full product life cycle, and quality assurance with commitment to compliance and excellence.Key competencies: - Quality, compliance, and regulatory requirements for FDA regulated products.- Developing a regulatory submission. - Document control and management with Good Documentation Practices. - Managing the Quality Management System (QMS) and experience with QSR. (21 CFR 820) - Compliance with ISO13485, ISO14971, 21 CFR 820, and IEC 62304. - Proficient in Lifecycle Management. - Good technical writing skills: authored SOPs, a clinical trial protocol, an Informed consent form, quality documents, and work instruction guidelines. - Risk management: Hazard Analysis (ISO 14971), Performing Failure Modes and Effects Analyses (FMEAs)- Design Controls (21 CFR 820)- Regulatory intelligence activities (FDA Database searches, data analysis, trend analysis, etc)- Quality Tools: Familiarity with common quality tools, such as Root Cause Analysis, 5 Whys, Fishbone Diagram, and FMEA.

Country

City

United States

Industry

Medical Device

Skill

ISO 13485, Project Management, Market Research, Project Delivery, Quality Procedures, Change Orders, SaMD, 510(k), Communication Training, Computer Literacy, Tablets, Pharmaceutics, Clinical Pharmacy, Leadership, Good Laboratory Practice (GLP), Regulatory Operations, Interpersonal Skills, Product Safety, Compliance Management, Technical Writing

Experience

Regulatory Specialist

QRx Partners

2026-3 - Present · 7 mos

Volunteer

CURE SYNGAP1, 501(c)(3) FKA SynGAP Research Fund (SRF)

2026-2 - 2026-4 · 3 mos

Regulatory Intern (capstone Project)

Vena Medical

2025-9 - 2025-12 · 4 mos

Quality Assurance and Regulatory Co-op

Dynocardia, Inc.

2025-1 - 2025-7 · 7 mos

Newton, MA

Regulatory Affairs and Quality Assurance Intern

SafeBeat Rx

2024-4 - 2024-11 · 8 mos

California, United States

Intern

Nutriventia

2023-1 - 2023-4 · 4 mos

Mumbai

- Researched the nutraceutical supplements market, contributing to the development of new product line for the company. - Researched various certifications required for health supplements and ensured the labels meet relevant regulatory guidelines. - Analyzed clinical trials data of 3 products, identified key findings to support the development of labelling claims and advertising. - Prepared detailed meeting minutes for discussions and meetings on affiliate marketing and market research, facilitating effective communication and alignment among team members and stakeholders. - Proactively engaged with 15 prospective clients and affiliates including nutritionists, dietitians, and gym trainers. Fostered strong relationships and improved sales growth by 20% through compelling written proposals, persuasive verbal presentations, and tailored communication strategies.

Social Media Coordinator

Principal K. M. Kundnani College of Pharmacy

2019-8 - 2021-8 · 2 yrs 1 mo

Quality Assurance Intern

Celogen Pharma Private Limited

2021-6 - 2021-6 · 1 mo

Mumbai

- Assisted with 4 projects in Formulation & Development department in 2 therapeutic areas, diabetes and cardiovascular. - Conducted in-process quality control tests on tablets (weight, thickness, hardness, disintegration, friability) as per manufacturing batch record instructions. - Ensured compliance with ALCOA standards for rigorous and accurate documentation and record management of experimental results. - Prepared in-process and finished product samples, following documentation procedures and delivering the samples to QC lab. - Followed internal protocols, Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).