Quality Assurance Assistant

Dinesh Puppala

**** ** **** ****** ***: ***D Baltimore, MD 21218 +1-443-***-**** ******@****.***

Johns Hopkins University, Baltimore, MD

EDUCATION

Master of Science in Regulatory Science Dec 2014

GPA 3.82

JNTU University, India

B.S M.Tech Dual degree in Biotechnology 2013

GPA 3.66

RELAVENT

EXPERIENCE RTI Surgical, Marquette MI 06/2014 – 09/2014

Regulatory Affairs Intern

• Submitted Traditional 510(k) application for Disposable Dilators used in conjunction with

Nerve Monitoring Cable.

• Filing documentation for applicable Regulatory bodies, both local and international.

• Reviewed Medical Device Regulatory standards and updates to ensure compliance.

• Preparation of Technical Files and Declarations of Conformity (MDD).

• Processed and updated CFGs.

• Assisted in UDI process development and Pedicle Screws re classification (OSMA)

• Assisted with support for CAPA & IQA program.

Johns Hopkins School of Medicine, Department of Psychiatry 09/2013 Present

Graduate Research Assistant

• Management of databases for site specific and multi site research projects.

• Consolidated IRB regulations and Informed consent forms.

• Interaction with multidisciplinary clinical and research teams.

• Maintaining inventory and clinical engineering certification of devices used in various

projects along with regulatory binder for Capsaicin.

Orchid Pharmaceuticals

UNDERGRAD

INTERNSHIPS

Regulatory Affairs Intern

Assisted with electronic filing of regulatory affairs records and submissions.

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Conducted research and performed data analysis, gaining a good perspective

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compliance methodologies, Designing dossiers and technical e filing.

Sanofi Group: Shanta Biotech

Quality Assurance Intern

Simulated project following cGMPs for its preparation and drafted a sample

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SOP.

Assisted with administrative tasks such as chart audits, and was given increased

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responsibilities and recognition for a job well done.

Investigational off label use of Transcranial direct current stimulation (tDCS) medical

PROJECTS

device regulation for therapeutic uses in brain stimulation for dopamine enhancing. (NIH

funded project)

Developing behavioral and neurobiological models to understand the influence of

positive emotion and reward processing on pain sensitivity.

RELATED IVD regulatory requirements; Global ICH laws; Quality System Regulations; cGMP

COURSEWORK Compliance; Good Laboratory practices; FDA laws & compliance, PMA 510(k); Technology

Transfer & Commercialization; Technical Writing in a Regulated Environment; Translational

Biotechnology: From Intellectual Property to Licensing.

BCIL Student Scholarship, 2012

HONORS/AWARD

JNTU Merit Scholarship, 2009

Awarded Best Speaker at National Tuberculosis Awareness symposium.

Office Interface: Microsoft Office (Advanced), Microsoft ACCESS, Filemaker.

COMPUTER SKILLS

FDA Tools : e Submitter, Open FDA, STED’s and eCTD formats

Bioinformatics : Mol Quest (gene finder), RNAfold, BLAST

Statistics : SPSS, R programming

Data Acquisition : LabChart PowerLab

Jama Cocoa: Student Startup which creates single origin chocolate in Baltimore: Media

VOLUNTEER

ACTIVITIES Manager, Blog Writing and social media.

Student Employment Services JHU: Office Assistant performing clerical work.

Hopkins Biotech Network: newsletter and email communications with staff.

IGSA Student Chapter: Web site design and maintenance and content creation.

Johns Hopkins UNICEF – Volunteer

Affiliations: Regulatory Affairs Professionals Society

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