Medical Device Project

NIKHIL KHANNA

Apt *** **** W **th Street, Los Angeles, CA -90007 • (213) 880 – 3241 • ***************@*****.***

SUMMARY OF QUALIFICATIONS

• Extensive experience in business analysis / project management with a focus on Requirements Analysis, Project Co-ordination, Problem Determination/Issue Resolution and Documentation.

• Collecting, understanding and reviewing business requirements, and translating them into Functional Specifications, System Requirements and detailed Test Plans.

• Experience in planning, developing and making presentations to management, communicating technical information, prioritizing and maintaining effective working relationship with IT teams.

• Knowledge of creating UML Diagrams, Data Models including Use Case Diagrams, State chart Diagrams, Collaboration Diagrams, Data Flow Diagrams (DFD) and Entity-Relationship diagrams using MS Visio.

• Good experience in Process Modelling, GAP Analysis, Risk Analysis, SWOT Analysis.

• Extensive knowledge and project experience of the 21 CFR 821 Medical Device regulations. In addition, also have knowledge and certified as an auditor for ISO 13485 Medical device regulations.

• Profound knowledge and experience of the United States FDA regulatory requirements for medical devices and multiple project experience with drafting 510(k) submissions for substantial equivalence, PMA for class 2 and class 3 medical devices.

• Good knowledge about the regulatory frameworks of the E.U., India, Japan, Australia, Canada, New Zealand, China and Latin American countries.

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EDUCATION

• University of Southern California, CA (May 2012)

Master’s of Science in Biomedical Engineering (Medical Devices and Diagnostics Engineering.

• University of Mumbai, India (August 2009)

Bachelor’s of Engineering in Electronics and Telecommunication Engineering.

SKILLS

Training ISO 9001-2000, ISO 13485, AS 9100, ISO 37000; 2009, 21 CFR 820, 21 CFR 821, cGMPs, cGCPs, cGLPs, CAPA, Six-Sigma, DMAIC, Quality Systems, FMECA, Quality Audits.

¬¬ Tools ¬ MS Visio, MS Project, Minitab, MS Word, MS Excel, MS Power Point, Macromedia Dream Weaver, Adobe Acrobat.

RELATED COURSEWORK

Quality Management, Strategic management of technology, Advanced topics in Biomedical Systems, Development and Regulation of Medical products, Regulation of Medical Devices, International approaches to Medical Product Regulation, Medical Products and the Law, Biomedical measurement and instrumentation, Signals and systems and engineering project management.

CERTIFICATIONS

• Six-Sigma Green Belt Certification (Indian Statistical Institute, Pune, India).

• ISO 13485-Medical Device Certification (British Standards Institute, Mumbai, India).

• Orange County Regulatory Affairs Training Certification (OCRA Committee, Orange, California).

PROFESSIONAL EXPERIENCE

AIR INDIA ltd, India (May 2011- July 2011)

Project Description - Worked as a Quality Engineering Intern.

Responsibilities –

• Fully responsible for requirements gathering and documentation. Organized and conducted extensive JAD sessions with users to identify, understand and document requirements.

• Develop process, standards, and procedures to create a Business requirement document.

• Responsible for developing flowcharts for the new Quality Management System and validating the system in accordance with business and functional requirements.

• Evaluated existing practices of storing and handling important data for Compliance.

• Developed test plans and test cases according to business requirements.

• Maintained Test Matrix with the test results obtained.

• Helped in writing and formatting SOP’s for Engineering and utilities.

AIR INDIA ltd, India (June 2009-Sept 2009)

Project Description – Worked as an Electronics Overhaul Intern.

Responsibilities –

• Overhauled various navigation and communication equipments like SELCAL, Black box, HF-VHF Trans-receivers, Weather Radars, Doppler Radars, RF-couplers, ADF, ILS etc.

• Fully responsible for documentation and updating the entire equipment history filing system.

• Conducted testing and performed regression analysis of the data in order to maintain quality.

• Performed corrective action and preventive action as part of the preventive and corrective maintenance plan for the equipments.

PROJECT WORK

Introduction of Fuel Cell powered Vehicles - Created a road map for the introduction of fuel cell vehicles as an alternative to combustion engines in motor vehicles using several statistical tools including SWOT analysis, GAP analysis, Process mapping, Risk Analysis, Product life cycle and extinction, Financial Resource mapping, Infrastructure and Value Stream mapping.

Developing Medical Device in USA - The project was to develop a unique medical product. The project included several aspects like Design, Resource allocation, Market reimbursement, Clinical trial strategy, Traditional 510(k) for substantial equivalence, Risk analysis and Mitigation.

US FDA 510(K) Submission - Drafted a traditional 510(K) for a class 2 device. Included several special controls listed in the guidance document by FDA. It included SE table, Risk analysis, Biocompatibility testing, Labelling.

Drug Development in India –Drafted a detailed analysis about the regulatory framework, clinical trial plan, target population, market reimbursement and launch strategy to successfully launch a drug in India.

Dental Adhesives Regulatory Strategy for US FDA- Developed a regulatory strategy based on the real situation of zinc adhesives. Strategy included making changes to existing label as a temporary solution and development of zinc free formula as a permanent solution.

Pharmacovigilance in the E.U. – Proposed a comprehensive plan to conduct Pharmacovigilance in the E.U. for an anti-inflammatory drug taking into account the present regulations of the member states and the EMA and also the new legislation on Pharmacovigilance which would be active from July 2012.

Clinical Trials in the U.K. – Proposed a plan to conduct clinical trials in the U.K. for the paediatric population in order to successfully launch a novel drug in the country combined with detailed analysis of E.U. and U.S. framework for the future launch of the product in these markets. Project included aspects like Market Analysis, Market reimbursement, Resource planning and scheduling, Regulatory Framework and Clinical trials.

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