Quality Control Medical Device

Chinmayi Naik

** ****** ******, ** ***** PHONE: 857-***-**** E-MAIL: ********.******@*****.*** Education

Northeastern University, Boston, MA Sept 2015- present Master of Science Regulatory Affairs for Drugs, Biologics, and Medical Devices GPA 3.92/4.0 Courses: Introduction to Drug and Medical devices, New Drug Development, Human Experimentation, Biologics development, Medical Device Development, Clinical Trial Design Optimization and Problem Solving, European Medical Device Regulation, Strategic Planning and Project Management University of Mumbai, Mumbai, India April 2015

Bachelors of Pharmaceutical Sciences GPA 3.66/4.0

Activities: Editor of college magazine ‘The Nest’ (2012-2013), Class Representative (2014-2015), Student Council Member (2012-2013 and 2014-2015)

Skills:

Proficient with Microsoft office (word, excel, outlook, Power point) Submissions: IND, ICH, GCP, GLP, eCTD, NDA, Post Approval Changes, BLA Strong knowledge of 510k, PMA, DHHS regulations, premarket notification for software guidance documents, QSR, GxP, MDR, EU EMEA regulations, CE marking. Basic knowledge of IMRDF, ISO and IEC standards, ISO 13485, ISO 14971 Academic Projects

Northeastern University, Boston, MA Sept 2015-Dec 2015

Preparation of Investigational drug labelling, Clinical protocol and informed consent form, Pre-IND Meeting request, IRB review report preparation, New IND Submission (eCTD format), Prepared a cover letter for BLA supplement BrainSpec, Boston, MA April 2016- June 2016

Experiential Network Project- Regulatory Strategy

Successfully coordinated and prepared a report detailing 510(k) documentation for innovative software used for diagnostic purpose. Using FOIA requested for 510(k) submission for relevant predicated device on USFDA website

Studied various predicate devices and analyzed information that can be used for BrainSpec 510(k) submission

Provided detailed information on validation testing, cyber security required for device Experiences:

Northeastern University, Boston, MA June2016- Present Research Assistant for Sharp Experiment at College of Engineering

Handled double blind placebo controlled phase 2a clinical study to evaluate cognitive functions of brain after transcranial stimulation

Explained the informed consent form and functioned as test administrator for MITRE test and other screening tests

Performed EEG cap setup, electrode placement on scalp, measured and supervised EEG signals Excel Biolife Pvt.Ltd., Mumbai, India May 2015-Aug 2015 Intern- Regulatory Affairs Officer in Regulatory Affairs Department

Compiled data for product dossiers, updated Raw material Specifications and Method of Analysis

Query reply preparation and compilation under HOD’s Guidance AGOG Pharma Ltd., Mumbai, India May 2014- July 2014 Intern- Quality Control and Production Departments

Learned about the large scale manufacturing process for tablets, capsules, liquid orals and external preparation from raw materials to finished product

Assisted Production manager in production department of tablets, capsules, liquid orals and external preparation

Performed In-Process Quality Control Tests in Quality Control and Quality Assurance department Jagjivan Ram Hospital, Mumbai, India June 2013- June 2013 Trainee Pharmacist

Gained proficiency in dispensing of medicines and patient counselling

Maintained inventory control, supply and demand of orders Superior Chemist and Druggist, Mumbai, India May 2012-August 2012 and July 2013-Aug 2013 Trainee Pharmacist

Dispensed medicines as per prescription and maintained inventory control.

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