Medical Device Project

KRUTI TRIVEDI

********@*****.**.** 682-***-****

SUMMARY: Reliable and passionate regulatory affairs professional with 5 years of experience in life science industry and able to work efficiently in cross-functional team as well as effective independent worker.

TECHNICAL EXPERTISE:

Drug/Biologics/Medical device/Medical Device current regulation for USA and Europe

ANDA, NDA, 510k, PMA and Letter to File preparation, DMF review

Post-Approval activities- PAS, CBE-30 and CBE-0 and Annual reports

Review Technical documents (BMR, labeling, stability analytical reports, SOP, CAPA), Change control review

eCTD Compilation and Publishing the documents with software- Trackwise, Documentum, Educe

Knowledge of 21CFR 820, ISO 13485, CE marking

WORK EXPERIENCE:

Senior Regulatory Affairs Specialist at Mylan Pharmaceutical, Pittsburgh Area, October 2017 to Present

Responsible for preparing and submitting of amendments and supplements for INDs, NDAs and ANDAs for FDA approval

Reviewing and approving change control and assess the appropriate regulatory reporting mechanism using FDA regulations, guidance documents

Responsible for reviewing of documents like BMR, labeling, product distribution reports, analytical procedures, product specifications, manufacturing batch records, in-process specifications

Interacting with multiple departments (QA, QC, Manufacturing Purchasing, R&D, etc.).

Using the Trackwise system for change control management.

Responsible for tracking ANDA commitments made to FDA to ensure that these commitments are honored and reported in a timely manner.

Project Internship: Regulatory Affairs Intern at ARMR Systems, Boston MA. April 2017 to July 2017

Helped the team to prepare regulatory strategy for ARMR System’s Class-II medical device

Developed the device regulatory plan to market the device in Brazil

Prepared international market analysis

Developed an approach for international market launch of the device

Helped to identify market opportunities other than domestic market Regulatory Affairs Specialist at Zydus Cadila Healthcare. May 2012 to March 2015

Prepared and submitted over 50 Prior Approval Supplements, CBE-30, CBE-0 and annual reports.

Reviewed around15 Drug master file (DMF) for ANDA preparation.

Responsible for preparing Drug substance part in ANDA. Prepared around 20 Drug substance part for ANDA.

Compiled approximately 20 ANDA in eCTD format and Published them ANDA with Educe Software.

Interacted with various department/teams to guide them for different regulatory requirements guide them for different regulatory requirements require for regulatory compilation on time as per regulatory norms.

Reviewed and approved and maintain various technical files like Batch manufacturing record, Batch packing record, Process validation protocol and reports, Analytical documents, Method validation reports.

Supported senior to prepare deficiency responses Regulatory Affairs Intern at Gujarat Liqui Pharmacaps Pvt Ltd. February 2011 to March 2012

Research focused on preparation of soft gelatin capsules of anti- anginal agent, which increases the shelf life and bioavailability of the drug product.

Prepared dossier of the same drug product for filing in semi-regulated market

Developed formulation to reduce the crosslinking of product Intern QA/RA Centurion Laboratories. May 2010- June 2010

Helped Regulatory Team to prepare and review various document. Example: BMR, BPR, Validation Protocol and Reports and SOPs

EDUCATION:

Northeastern University, Boston, MA. July 2016 to Present Master in Regulatory Affairs for Regulatory Affairs Drug, Biologics and Medical Device

Drug and medical device regulations: Basis US and EU regulation

Medical device development: Research Project with Letter to File for class- II device, Prepared Mock Regulatory 510k Filing.

Emerging trends and issue in medical device industry: Prepared projects on Minimed 670G system and PKG system for Parkinson’s disease - Class-III medical device

European Medical device regulations: Prepared project on Novel Device/Diagnostic System for commercialize in EU Gujarat University, Gujarat, India. September 2010 to May 2012 Master in Pharmacy, Pharmaceutics and Drug Design

Thesis- Novel Drug Delivery System for Anti-Anginal Ageny: Development, Evaluation and Dossier Preparation Qualified Graduate Pharmacy Aptitude Test(GPAT). May 2010

All India 2500 rank with full scholarship for higher education Sardar Patel University, Gujarat, India. August 2006 to June 2010 Bachelor of Pharmacy

Pharmacology, Medicinal chemistry, Pharmaceutics and Pharmaceutical Analysis PROJECTS:

1) National Level Pharma Tech Carnival, Pharma model making Working Model of Fluidized Bed Dryer-Prepared and presented working model of Fluidized Bed Dryer 2) State level advertisement competition

Advertisement of suture and ligature- Performed act on Marketing advertisement on suture

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