Medical Device Quality Assurance
Resume:
MEERA MEHTA
**C McGreevey Way, Boston, MA ***** *************@*****.***
Summary:
Hardworking, sincere, and detail oriented Regulatory Professional with
outstanding written, verbal and interpersonal communication skills.
Ability to manage multiple tasks, highly organized with efficient time-
management skills in deadline driven environment. Aptitude to apply
regulatory guidance, follow internal standards. Able to work
independently and take ownership of assigned tasks and projects.
Proven experience of serving as a regulatory team member on project teams
and implementing regulatory strategy for new product development.
Core Competencies:
. Familiarity and knowledge in the preparation of major regulatory
submissions; IND, NDA/ANDA, BLA, SAE, ADE reports for Drugs and
Biologics, License and Database submissions annual reporting's,
data management and supportive amendments or supplements and e-CTD
submission.
. Sound Knowledge of Regulatory submissions like IDE, PMA
supplements, Traditional and Special 510K/PMN, HDE, and STED for
Medical devices.
. A succinct understanding of European Union product regulations,
MAA, EU Design Dossiers, Approval procedures and timelines for
Medical Device products - CE marketing requirements.
. Well versed with Asia, Japan, Health Canada and Latin America
product classification, timelines and managing clinical trials.
. A detailed understanding of the involved processes in device
development, device recalls, MDR, CAPA, AEERS and Risk Management.
. Knowledge of ICH Guidelines, Quality Management Systems, GHTF
Guidelines, ISO 9001, ISO 13485, Quality Assurance/Control,
marketing and structure of clinical studies.
Educational Qualification:
Northeastern University College of Professional Studies, Boston MA
Apr 2013
Candidate of Master of Science in Regulatory Affairs for Drugs, Biologics
and Medical devices
Relevant Course Work:
New Drug Development, Biologics Development, European Union Compliance
Process and Regulatory Affairs, Medical device development, Global
Awareness: Introduction to Canadian, Asian, Japan and Latin American
Regulatory Affairs, Practical Aspects of Regulatory Compliance, Human
Experimentation, Clinical Drug Data Analysis, Food, Drug and Medical
Device Law.
Mumbai University, Mumbai - India
May 2011
Bachelor of Science in Pharmacy
Affiliates:
Member of Regulatory Affairs Professional Society (RAPS), Indian
Pharmaceutical Association (IPA)
Work Experience:
Intern, Liberal Pharmaceutical Company, Mumbai - India
Regulatory Law
May 2010 - Jul 2010
. Assisted in review of the entire quality system with management of
process deviations, annual product quality review, market
complaints, investigations, corrective and preventive actions, and
stability studies.
. Supported in preparation of SOP's Protocols and Reports.
. Reviewed and assisted in the preparation of USDMFs, EDMFs and
dossier filing.
Manufacturing and Quality management
May 2009 - Jul 2009
. Trained in Manufacturing and Packaging of Tablets, Capsules (Hard
and Soft Gelatin Capsules), Syrups and Parenteral.
. Reviewed the labeling, batch records, quality test methods for
compliance with applicable regulations and policies.
Skills:
Computer Skills: MS Word, MS Excel Spreadsheet, MS PowerPoint, Microsoft
Outlook and Windows Operating System, Mac.
Presentation and Projects:
. Regulatory Development Plan:
Mar 2012
. Detailed study of indication assigned, its prevalence, and overall
affected patient population. Inclusion of sections on preclinical,
clinical, nonclinical, bioequivalence and CMC data. Incorporation
of proposed study designs and all essential regulatory milestones.
. Development of regulatory submission plan Class II medical device:
Mar 2012
Anterior Spinal Plate, a Class II device was originally 510(k) cleared.
New plan was to address same device with different intended use and
patient population. The plan was devised upon utilization of 21 CFR 807,
21 CFR 814, 21 CFR 820, Labeling guidance and all possible relevant FDA
CFRs and guidance documents. The plan also included requirements
regarding registration, listing, device classification, advertising, and
promotion.
. Submitted paper on "Medical Device Classification Product Codes"
Jan 2012
. Overview of development of regulations for Biologic products in
United States
Biologics Control Act of 1902 through amendments of 1919 till
establishment of Center for Biologics Evaluation Research [CBER] -
gathering understanding behind objective of these developments.
. Submitted mini tutorial on "Pharmacogenomics: Reducing sample size,
time, money and risk?" Dec 2011
. Presented a team project on "Contrasting and comparing the
similarities and differences between Q10 quality systems for
Pharmaceuticals, guide to combination products and the GMPs"
Nov 2011
. Presented and submitted position paper on "Pediatric Clinical
Trials: Are children simply small adults?" Oct 2011
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