• Identifying, creating and completing the appropriate documentation required for new design and design modifications including but not limited to design change forms, project initiation requests, design inputs and verification documentation, design transfer documents, design validation documentation modifications• Responsible for accuracy of design transfer activities including but not limited to: product andprocess procedures and documentation, quality system procedure, device master records,product labeling, material specifications, etc.• Writing/Drafting, reviewing & revising Technical Files, Essential Requirements checklists & Declaration of Conformity to ensure the latest regulatory requirements are met for 1000+ Class I & Class II medical devices • Responding to regulatory authority inquiries under strict deadlines• Interfacing with notified bodies during on & off site audits • Acting as primary contact for EU authorized representative and notified body for standard activities• Reviewing regulatory standards and making sure that the documentation is in compliance • Creating & updating risk management files (RMF)• Approving Design Change Notifications (DCN)• Initiating supplier approval requests• Updating Canada licenses & creating UDI• Managing product lifecycle activities including regulatory impact assessments of product changes and product labeling development• Providing regulatory assessment for changes to product design and manufacturing processes• Acting as the project leader for new product development and design changes• Creating Project Plans and timelines; prioritizing projects & aligning resources• Acting as a liaison between the sales and marketing team and the manufacturing/production team• Coordinating with cross functional teams to ensure timely completion of projects • Developing new processes and SOPs• Communicating status update, identifying potential risks and updating senior management and client

• Supporting regulatory submissions for assigned new and/or modified products as required to ensure timely approval for market release and in accordance with applicable regulations, standards and guidance• Reviewing labeling for assigned products for regulatory compliance, in particular ensuring labels, instruction for use, and promotional materials conform to product clearances, approvals and licenses• Assessing and documenting impact of proposed product changes on regulatory filings• Maintaining regulatory affairs product files to support compliance with requirements and standards. Supporting the generation and update of technical files and declarations of conformity• Assisting with regulatory audits from partners and external regulatory agencies• Draft and update regulatory affairs procedures• Maintaining current knowledge of the developments and changes to applicable laws, regulations and industry standards, and assisting in the dissemination of this information to the appropriate individuals within the company and sector

Regulatory Affairs Associate – Medical Devices• Serving as a lead regulatory representative for assigned project teams• Providing regulatory advice and support to assigned products/teams• Identifying and communicating regulatory needs and strategies• Obtaining Certificates to Foreign Government (CFG) from FDA and getting these legalized or apostilled• Facilitating the importation of medical devices into US by proactively preparing and providing product use and registration documentation to FDA and US Customs• Preparing End User Letters to ensure favorable disposition when materials are detained by FDA Compliance Officers• Providing regulatory support in preparation for FDA auditsSenior Regulatory Affairs Specialist - Pharmaceuticals• Conducted gap assessment of Module 3 CTD sections using applicable regulatory guidance and pharmacopeias• Identified the risk level of assessed gaps and communicated to senior management• Conducted remediation of the approved regulatory file information with respect to alignment with Corporate specifications and manufacturing procedures • Prepared and submitted regulatory applications to FDA where required• Revised and updated Corporate document used for Annual reports, Post-Approval Supplements(PAS) and to identify impact on (A)NDA applications

• Supported the global extent of e-submissions, documentation, and ensured all regulatory documents and submissions were complete, accurate and well maintained in the registration management databases • Compiled and created regulatory submissions, including initial registration applications, deficiency letters, renewal and variation packages for MRP, DCP and National Procedures in CTD, ACTD, and non-standard structures • Processed electronic files incorporating bookmarks, links and other formatting requirements; managed documentation according to the regulatory guidelines to ensure traceability• Created submission planners, workflows and routed documents for approval

• Carried out thorough assessment of validation and verification reports• Conducted gap assessments for test methods related to regulatory submissions, assessment done against USP and EP• Compiled documents and made sure pre-developed Gap Assessments were completed for compliance with internal and external requirements• Carried out technical review of validation documents, compendial methods, approved test methods and client quality systems and compliance documentation• Organized completed technical gap assessment procedures that required evaluation of documents and comparison of test methods to source documents• Prepared documentation of gap assessments and product summary packets for filing either electronically or in paper format within client document control systems

• Conducted one-on-one and group sessions to instruct college level Chemistry. Work involved close interaction with diverse group of people with different abilities

o Developed marketing materials for distribution to prospective clients.o Contacted prospective clients to explain product portfolio.o Managed client accounts including contact information, shipping of product samples, generating invoice, tracking payments and answering business queries.

o Volunteered at local institutions including district schools, PTA, Girl Scouts

Conducted scientific research to study Cytoskeletal disruption and small heat shock proteins (HSPs) translocation. Managed the lab single handedly to produce consistent, timely and accurate results. Analyzed research data and helped prepare presentation material.o Sample preparation, testing and analysis.o Record raw data according to GLP documentation requirements.o Calibrate lab instruments.o Develop and validate efficient analytical methods for best experimental results.o Characterize and identify compounds of interest.o Maintain chemical and biological raw material inventory.o Ensure regulatory compliance and certifications.o Manage proper handling, storage and disposal of hazardous materials.o Document laboratory protocols and procedures for chemicals and instrumentation used.o Compiled, validated and analyzed experimental data.o Prepared technical reports on completed studies and provided expert opinions to interpret results for research sponsors and data users.o Communicated results utilizing verbal, electronic or written means as required to facilitate utilization of data.o Ensure up to date laboratory manuals maintenance and maintenance of safe laboratory environment.o Based on research findings recommended options for future research projects.

Ran Serology tests on more than 700 samples each day with high accuracy. Compiled and reported the results to responsible party.• Prepare chemical reagents and solutions.• Extensively used spectro-photometers, spectrometer, dilutors and automatic pipettes to run Serology tests on more than 700 samples each day with high accuracy. • Compiled and reported the results to responsible party.• Followed Quality Assurance and Quality Controls procedures for consistent and accurate results.