Regulatory Affairs Consultant

Sushmitha Sampath

********@***.*** +1-323-***-**** PORTFOLIO LINKEDIN bit.ly/sushmithasampath

SUMMARY

I am a highly motivated and result-driven regulatory affairs professional with background in biomedical engineering. I have experience in Regulatory Submissions (FDA, EU and China), Quality Assurance and marketing strategies for medical products. I have RAPS certification in Global Regulatory Strategy for Medical Device. EDUCATION

University of Southern California, Los Angeles, CA Expected: May ‘19 Master of Science in Medical Devices and Diagnostic Engineering (STEM); GPA: 3.74/4.0 Relevant Coursework: Medical Product Regulation, Medical Regulations for Devices and Diagnostics, Quality Assurance for Medical Products and Combination Products, Directed Research Anna University, Chennai, India July ‘13- May ‘17

Bachelor of Engineering in Biomedical Engineering; GPA: 9.17/10.0 EXPERIENCE

USC International Regulatory Consulting Services, Regulatory Affairs Consultant Intern Feb’18 - Present

• Developed regulatory and marketing strategies for medical products to be marketed in U.S., Europe and China. Identified the regulatory pathway and quality requirements. Performed competitive analysis and analyzed market trends

• Prepared post- market and pre-market regulatory submissions including Annual Reports, IDE supplements, IDE, IND, 510(k), technical files for several products

• Responsible for establishment registration and product listing for clients with the FDA

• Reviewed the label and advertising materials including UDI requirements of medical devices to ensure compliance with regulatory requirements

• Developed a Risk Evaluation and Mitigation Strategy (REMS) for a De-Novo pediatric respiratory device. Identified the required risk management documents and performed REMS study for the product life-cycle. Performed risk analysis using FMEA. Provided a risk evaluation and risk controls report to the client

• Provided Internal Audit support for clinical trials. CITI certified in GCP auditing

• Collaborated with Department of Preventive Medicine-USC to prepare a Quality Assurance plan for the data analysis of clinical trials. Developed and implemented SOPs to maintain data integrity and quality.

• Presented global regulatory updates and seminars on regulatory topics Clinical and Translational Science Institute -NIH, Research Volunteer Sept’18-Present

• Developing contents for self-study tools for monitoring and auditing of clinical trials for research professionals

• Statistically analyze the response of focus-testing groups to continuously monitor and improve the contents of the modules PROJECTS

Regulatory Considerations for Companion Diagnostics in EU and US, Independent Research Jan’18-Present

• Researching regulatory strategy and analyzing reimbursement policies for Companion Diagnostics in EU and US

• Providing a comparative study between the requirements of EU and US to facilitate development of global regulatory strategy Architectural Design FMEA for Mobile Medical Applications, Independent Research June’18- Dec’18

• Researched existing risk analysis tools and proposed Architectural DFMEA for Mobile Medical Applications

• Analyzed the usefulness of Architectural DFMEA in CAPA and Lean Operations

• Submitted this proposal to RAPS Convergence 2019. Developing Regulatory Strategy for drug-development in the United States Jan’18- Apr’18

• Developed business strategy for a novel drug: competitive position, IPR, finance, reimbursement and marketing

• Suggested various business options available for early-to-market and reduction in cost SKILLS

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• Regulatory: FDA submissions (510(k), IND, IDE, Annual Reports), EU Technical File, FDA QSR, ISO 13485, MDR, MDSAP, ICH Quality: Risk Analysis tools (FMEA and FTA), CAPA, Complaint-Handling, Statistical Process Control, SOP, Auditing, Lean Six Sigma Software: Tableau, OnCore Clinical Trials Management System, Minitab, SPSS, Microsoft Office (Excel, Word, PowerPoint) Other : Technical Writing, Strategy, Consulting, Decision-Making, Cross-functional Leadership, Public Speaking CERTIFICATIONS AND PARTICIPATIONS

• Member of Regulatory Affairs Professional Society(RAPS) and RAPS certification in Global Regulation Strategy for Medical Devices.

• John Hopkins certification for the Design and Interpretation of Clinical Trials

(https://www.coursera.org/account/accomplishments/verify/RYD3MGNT2VLG)

• Participated in CTD/eCTD training organized by USC Regulatory Science department

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