Medical Device Quality Assurance

Priyank RajeshKumar Shah

** **** ******, *** # *, Somerville, MA 02145 617-***-**** ************@*****.***

SUMMARY

Regulatory Affairs Professional with scientific knowledge and industrial experience in filing ANDA’s and NDA’s for OTC products, documentation, registration of drug and medical device products in domestic and international market

Background comprises of Masters in Regulatory Affairs program and participation in compilation of product dossiers, drafting and reviewing documents for Medical Devices as well as OTC products for a generic drug company

EDUCATION

Northeastern University, Boston, MA June 2015

Masters of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices cGPA: 3.82 / 4.00 Relevant Courses: Introduction to Drug and Medical Device Regulation, Human Experimentation: Methodological Issues Fundamental to Clinical Trials, Medical Device Development and New Drug Development, Biologics Development: A QA/Regulatory Overview, European Union Compliance Process and Regulatory Affairs, Clinical Laboratory Management and Emerging Products Drugs/Biologics, Orphan Drug Development Food, Drug and Medical Device Law

Projects:

Compiled and analyzed official NDA, BLA cover sheets and components of eCTD submissions

Prepared and submitted a mock 510(k) regulatory filing for “PMMA Bone Cement Device” to the FDA

Prepared an Informed Consent and reviewed case studies on clinical trials

Completed 10 graduate level courses towards MS in Pharmaceutics & Drug Delivery earning a GPA of 3.75.

University of Mumbai, Mumbai, India May 2012

Bachelor of Pharmacy, Distinction GPA: 3.92 / 4.00

Licensed Pharmacist in India

SKILLS

Regulatory: Familiar with 510 K Submissions, IND, PMA, BLA, NDA, ANDA, IDA, FDA Regulations and Guidance’s, 21 CFR, IDE, Clinical Trials, GMP, GCP, GLP, CAPA, ICH Guidelines, Quality Assurance and Quality Control, EU and EMEA Regulations, CMC, PDUFA, Post-market Surveillance, IVD, Regulation of Combination Products, Labeling, ISO Standards, Quality Systems Regulations, UDI, eCTD submissions and Patient Advocacy Group

PROFESSIONAL EXPERIENCE

Bio-Pharm, Inc. September 2014 – March 2015

Co-op, Regulatory Affairs and Quality Assurance Associate

Member of the Regulatory and Compliance group assigned to perform timely and successful regulatory review and submissions

Compilation and preparation of ANDA and NDA related regulatory documents for dossier preparation and submission to Regulatory bodies and FDA

Member of the team involved in ANDA approval of Lactulose Solution

Reviewing proposed product changes for impact on regulatory status of the product

Responsible for the analysis, review and approval of Labels per 21 CFR part 820 and ISO 13485

Raise planned/unplanned/incidental deviation, raise CAPA and prepare deviation reports, investigation reports, change controls and certificate of analysis

Prepare change controls and make or revise SOP’s

Prepare, issue and review Batch Production and Control Records and Master Packaging Records

Ensure regulatory compliance of products with US, EU and international requirements for market approval of generic and OTC drugs and involved in eCTD submissions

Responsible for product's quality and safety through the use of Quality System

Reviewed labeling, batch records, specification sheets, or test methods for compliance

Member of the internal audit team and team handling FDA and DEA inspections

Coordinate CMC disciplines and guide the preparation for an NDA filing (including timelines, review cycles, coordinating CMC planning with Project Management and Regulatory Affairs departments)

Center for Pharmaceutical Biotechnology & Nanomedicine Jan 2013 – Jan 2014

Dr. Vladmir P. Torchilin’s Lab, Northeastern University

Research Assistant

Focus on Formulation and Characterization of Liposomal Drug Carriers; Compile and report on data

Prepared lab reports, presented results, compiled data on QA, QC and reviewed regulatory documents

Bombay Hospital, India May - June 2011

Summer Intern

Formulated and dispensed various prescription drugs; maintained hospital inventory

Aided in Documentation and Archiving of the drug inventory as per Indian regulatory laws

Assisted in regulatory submission of medical devices (510K) and Conducted the review of Device History Records (DHR)

Recruit patients for clinical study and record data accurately on research forms

Khandelwal Labs Pvt Ltd., India Nov - Dec 2011

Regulatory Affairs Intern

Oversaw the labeling process and drafted the protocols and manufacturing records

Assisted in writing QC testing protocols and report. Documented findings in Quality Control and Quality Assurance departments and reviewed regulatory documents

ACTIVITIES

Secured Second Place for poster presentation on “Plastic Antibodies” at IPA-SC 2010 conducted by IPA

Active member of American Association of Pharmaceutical Sciences

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