Medical Device Microsoft Office

KRUTI A. DAMANI

** ***** ********* ******, ******, MA 02120 617-***-**** ******.*@*****.***.***

CAREER OBJECTIVE

Goal-driven professional with broad proficiencies in pharmaceutical research and development, regulatory affairs, and compliance in national and global industry mandates.

SKILLS

Designed both 510(k) and PMA approval pathway for a Class II and Class III medical device.

Developed a SOP for Multiple Tube Fermentation Process.

Formulated a mock pre-IND meeting request letter for the FDA.

Drafted Informed Consent form, clinical research protocol, investigators brochure for a drug molecule.

Found deficiencies from a Warning Letter and suggested Preventive and Correction Action.

Calculated the pre-mitigated and post mitigated risks, to assess the safety of a medical device.

Analyzed keys points and milestones to be considered while taking the next steps in selling a Class II device in countries proposed outside the US/EU/EFTA.

Knowledge of regulatory agencies (FDA, CDSCO, Health Canada, EMA, SFDA and TGA).

Software- Microsoft Office (Word, Excel, PowerPoint, Outlook, Publisher), Java, SQL, Adobe Acrobat.

EDUCATION

Northeastern University, Boston, MA Sept 2016- July 2018

Master of Science- Regulatory Affairs for drugs, biologics and medical device

Nirma University, Ahmedabad, India August 2012- June 2016

Bachelors of Pharmacy

CERTIFICATION

NIH Web-based training course - Protecting Human Research Participants March 2017

PROFESSIONAL EXPERIENCE

Benmoon Pharmaceuticals, Ahmedabad, India May 2016- August 2016

Quality Assurance Intern

Reviewed and approved quality system documents to determine compliance with regulatory regulations and standards

Implemented cGMP while manufacturing of formulations and handled any deviations.

Assisted in packaging and distribution of drug products as per the regulations.

Conducted regulatory reviews of newly launched products based on CDSCO guidelines & regulations.

Medi Pharma, Ahmedabad, India Dec 2015- April 2016

Manufacturing Intern

Performed validation studies on raw materials and stability studies on packaging components, as per cGMP guidelines.

Assisted in the development and maintenance of regulatory files, records, and reporting systems.

Reviewed Regulatory Documents (SOP, Quality Manual pertaining to GxP) to assure company's compliance and participated in the relevant submissions to the local regulatory agency.

ACADEMIC PROJECTS

Experiential Network Project (MedTech Intelligence) July 2017- August 2017

Updated MedTech Intelligence’s QA/RA cheat sheet.

Verified all the websites on the page.

Provided new websites that can serve as resources for QA/RA professionals in the medical device industry

Experiential Network Project (Massachusetts General Hospital) Jan 2017- March 2017

Complied and submitted ANDA annual report of Ammonia N13 Injection.

Assisted in updating Module 1 (Regional Administrative Information) and Module 3 (Quality Information) of the original annual report.

Collected data and prepared the summary of new clinical trials conducted.

Researched for adverse events associated with Ammonia N13 Injection.

Thesis on International Drug Approval Procedures July 2015-March 2016

Reviewed regulatory framework, institutions and committees involved in drug regulation in India, United States, China and European Union.

Identified and highlighted the similarities and differences in the drug approval procedures.

Gained knowledge of drug development and pharmaceutical product regulatory approval process complying to various regulations.

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