Medical Device Quality Assurance

Avanti Sawant

** ***** ********* ******, *** # **5, Boston, MA 02120 617-***-****

******.********@*****.***

EDUCATION

Northeastern University, Boston, MA April 2014

College of Professional Studies

Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices

Related Courses: Medical Device Development: Regulatory Overview, Drug and Medical Device Development,

New Drug Development: Regulatory Overview, Human Experimentation, Biologics Development: Regulatory

Overview, Emerging Products: Drugs and Biologics, European Union Compliance, Regulations of Generics and

Biosimilars, Food Drug and Medical Device Law, Supplier Risk Management for Medical Devices and Drugs

Related Projects: Case studies based on understanding of IND/ NDA/ BLA submissions, 510(k)/IDE/PMA

Submissions, E6 GCP guidelines, Medical Device Reporting (Form 3500A), working of QSR, Informed Consent

Document (ICD), 21 CFR 210, 21 CFR 211, 21 CFR 803 and 21 CFR 820, Device Listing Process, CAPA, Medical

device listing and establishment registration licensing, CAPAs, Medical Device Regulations, CE Marking

University of Mumbai, Mumbai, India June 2012

Bombay College of Pharmacy

Bachelor of Science in Pharmacy

Related Courses: Medicinal Chemistry and Pharmaceutical Analysis, Biochemistry, Pharmacology, Anatomy

Physiology and Pathophysiology, Pharmaceutical Jurisprudence, Forensic Pharmacy, Pharmaceutics, Hospital

Pharmacy and Drug Store Management

PROFESSIONAL EXPERIENCE

Godiva Chocolatier Inc., Reading, PA July 2013- December 2013

Regulatory Affairs and Quality Assurance Co-op

Reviewed product label proofs by application of Global Food Labeling Regulations

Communicated with regulatory agencies for license registration and renewal updates

Conducted regulatory compliance checks using Food Additive Database and Decernis Library for New

Market Entries and country-specific regulations for Product Development Team

Worked on Product Lifecycle Management (PLM) and Product Approval Tool (PAT)

Compiled a Packaging Manual based on Global packaging specifications for suppliers

Pfizer India Ltd, Mumbai, India July 2012- August 2012

Regulatory Intern

Reviewed pharmaceutical artwork by application of rules from FD&C Act and ICH Guidelines

Supported functioning of Medical and Regulatory Department by managing database on excel spreadsheets

Assisted experts in data collection and eCTD submissions

Familiarized with Clinical Trial Study Design, Informed Consent Documentation, Ethics Committee

Gained knowledge on Import Licenses, Patent Registration process, Regulatory scenario in India

Sandoz Pvt Ltd, Kalwe, India April 2011- May 2011

Industrial Trainee

Gained working knowledge on SOPs, rules for labeling, packaging and GMPs

Exposed to the functioning of all departments including Quality Assurance, Quality Control, Production,

Warehousing, Supply-chain Management, Human Resource Management, HVAC and Microbiological

Testing

REULATORY SKILLS

Proficient on basic Computer programs: Microsoft Office- W ord, Excel, Share point, Outlook, Power Point

Understanding of 21 CFR, FDA guidance documents, Electronic Submission Gateway(ESG)

Structured Product Labeling, knowledge of ANDA, NDA, IND, BLA and related FDA submissions

Contact this candidate