Risk Management Regulatory Compliance

AMRUTA KAKADE

+1-206-***-**** ********@**.*** LinkedIn Seattle, USA

EDUCATION

University of Washington Seattle, USA

Master of Science, Regulatory Affairs September 2023 – (Expected) May 2025 MIT-ADT University, MIT School of Bioengineering Pune, India Bachelor of Technology, Bio-Engineering June 2017 - July 2021 SKILLS

●Technical Skills: Regulatory Compliance: FDA (21 CFR 820, 21 CFR 11, 510(k), De Novo, PMA), Health Canada (Class III & IV), EU MDR, ISO 13485, ISO 17025, ISO 20387, ISO 10993 Technical Writing & Documentation: Regulatory submissions, Post-Market Clinical Follow-up (PMCF), Periodic Safety Update Reports (PSUR), Risk Management

●Soft Skills: Analyzing and Addressing Challenges, Precision, Making Informed Choices, Guiding and Collaborating with Others, Arranging and Strategizing, Persistence, and Effective Communication

●Software Skills: Google Workspace, Microsoft Office, and ERP EXPERIENCE

OWLET BABY CARE, INC.Utah, USA

Regulatory Intern October 2024 - Present

● Conducted background research on regulations, guidelines, and industry resources, and performed a literature review to support compliance, product development, and decision-making for smart baby monitor device

● Analyzed post-market safety data to ensure regulatory compliance and support risk management

● Contributed to the preparation of Periodic Safety Update Report (PSUR) and Post-Market Clinical Follow-up (PMCF) Report, ensuring alignment with EU MDR

ORTHOHEAL PVT. LTD.Vadodara, India

Research Associate December 2022 - June 2023

● Led the Implementation of 1st ever Tissue Bank for bone allograft processing and storage in Gujarat, India

● Applied advanced research in knee and spine optimization, contributing to significant advancements in the treatment of osteoarthritis and scoliosis

● Conducted an in-depth research and executed comprehensive root cause analysis for FlexiOH technology, an orthopedic immobilizer

● Managed and maintained the Intellectual Property Rights documentation pertaining to 2+ innovations

● Drafted comprehensive business plans, pitch decks, and white papers to articulate project strategies with precision and impact ANDHRA PRADESH MED TECH ZONE Visakhapatnam, India

Regulatory Fellow January 2021 - April 2022

● Acquired NABL accreditation for EMI / EMC Testing laboratory as per ISO 17025:2017

● Served as technical liaison for 3+ project partners from conceptualization to implementation and product launches

● Conducted research for knee brace in rehabilitation and assistive technology

● Designed and developed a project to improve Operation Theatre (OT) lights, achieving a 20% boost in brightness and energy efficiency

● Abetted in the Pre-compliance testing of 10 device prototypes and reviewed the EMI/EMC concepts

● Performed extensive research on Bionic Arm, rectified inefficiencies, and enhanced functionality by 15%

● Actively interacted with subject matter experts and documented project requirements for startups focusing on orthopedic innovations

● Initiated 3+ government-granted projects successfully by managing financial and technical bids ACADEMIC PROJECTS

●Hydrothermal decoration of nano-silver on the surface of galactomannan-modified ZnO and their catalytic, bactericidal, and bio-sensing applications

●Authored a project life cycle study for MedTech product development in a government organization

●Conducted regulatory assessment for a novel product Sipl-E-Vac which will be used for the treatment of gastrointestinal leaks

●Devised an innovation strategy and business plan for XR technology in Physical Therapy

●Independent Study- Commented (Comment ID: FDA-2022-D-2997-0056) on the FDA draft guidance “Key Information and Facilitating Understanding in Informed Consent Guidance” under Docket ID: FDA-2022-D-2997. LEADERSHIP EXPERIENCE

●Served as a volunteer for corporate communications in the Organization Of Regulatory And Clinical Associates (ORCA) and organized seminars with regulatory industry leaders

●Competed in the Hollomon Health Innovation Challenge 2024 organized by the Buerk Center for Entrepreneurship at the University of Washington and presented PT.AR, a novel home-based PT solution to enhance patients' adherence to prescribed physical exercises CERTIFICATIONS

●Biobanking Quality Management System and Internal Auditor Training Course as per ISO 20387:2018 by Quality & Accreditation Institute (QAI)

●Medical devices Quality management systems and Internal Auditor Training Program based on ISO 13485:2016 by TUV SUD South Asia Private Limited

●Understanding How Medical Devices are Regulated in Canada by Health Canada

●Introduction to FDA Human Drug Review and Approval Basics by FDA

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