Medical Device

MITALI KATKAR

Boston, MA ***** ************.***@*****.*** +1-617-***-**** www.linkedin.com/in/mitali-katkar PROFESSIONAL SUMMARY

An energetic self-starter, goal-oriented leader with a passion for improvement and an eye for detail. Excels at working in a dynamic environment & handling multiple projects efficiently. Ambitious & highly organized enjoys bringing a positive change in the processes, has a commitment to growth, & the ability to perform under pressure and deliver high quality results. EDUCATION

Northeastern University, Boston, MA Jan 2019 - Apr 2021 Master of Science in Regulatory Affairs

Pune University, Pune, India Aug 2013 - Sep 2017

Bachelor’s in Pharmacy

CORE COMPETENCIES

Regulatory Affairs

§ 510K, PMA, IVD, HDE, AL/ML based SaMD

§ ISO 13485, ISO 14971, IEC 60601, ICH

§ EU MDD, MDR 2017/745, STEDs, UDI

§ GLP, GMP, 21 CFR 820, CAPA, Labeling

§ MDSAP, Device Registration & Licensing

Clinical Operations

§ IDE, IRBs, Clinical Study Protocol

§ ICH guidelines: HIPAA, GCP Studies

§ Clinical Trials, Clinical Study Design

§ Clinical Monitoring Plan, ICF

§ SSU activity, Study Closure Submission

Technical Knowledge

§ Veeva Vault, ISI Writer, Access

§ Microsoft Word, Excel, Power Point

§ Adobe Acrobat, SharePoint, Outlook

§ eCTD Viewer, Federal Register

§ EudraCT, EudraVigilance, MAUDE

PROFESSIONAL EXPERIENCE

China Med Device, Andover, MA Regulatory Intelligence Capstone Project Jan 2021 - Apr 2021

§ Conducted research to develop global regulatory strategies for new & modified medical devices in US, EU, Japan, India & Australia

§ Identifying country specific regulations, guidelines & mapping out regulatory hurdles for all device classes including Software Device Advanced Skills: Regulatory Plan, International Medical Device Regulations, SaMD, Leadership Kalia Health, Chapel Hill, NC Clinical & Regulatory Project Intern - Experiential Network Sep 2020 - Dec 2020

§ Tasked in preparation of De Novo Application template per FDA guidance “De Novo Classification Process”

§ Prepared in-depth review of regulatory data & documentations for Adverse Events Reporting including MedWatch Form

§ Determined GCP requirements and supported Trial Master File by drafting monitoring site visit report template, periodic monitoring visit log and Delegation of Authority log for a clinical study of an in vitro diagnostic device

§ Analyzed evolving global regulation for Class II IVD pertaining to submissions, Risk Management and Quality Managementt system Advanced Skills: IVDs, De Novo, AE Reporting (FDA MedWatch Form 3500), Trial Master File Momenta Pharmaceuticals, Cambridge, MA Regulatory Affairs Co-op Jan 2020 - Jun 2020

§ Supported IND maintenance through preparation of cover letters and Form 1571 for (4) Initial & Follow-up IND Safety Reports

§ Independently prepared (12) New Investigator submissions & (2)1572 Waiver Request submission to FDA within mandatory timelines

§ Assisted in preparation of regulatory submissions including Type C Meeting Request, Preliminary Breakthrough Therapy Designation, DSUR and attended weekly meetings with cross functional teams (Clin-Ops, Regulatory & CMC)

§ Spearheaded training for Corporate on binder preparation, maintaining correspondence (FDA, EMA, Health Canada) using Veeva

§ Utilized Veeva, Share Point, ICON Box for maintaining clinical trial documents, HA questions, responses & submissions

§ Responsible for tracking and compiling Health Canada submissions - CTA, CTSI, Information requests, Meeting Package

§ Assisted in SOP development & performed quality control of Protocol Amendments, Investigator’s Brochure & Statistical Analysis Plan Advanced Skills: e-DMS-Veeva, IND, Safety Reports, Type C Meeting Request, HA questions & correspondences Breegi Scientific, Boston, MA Regulatory Project Intern - Experiential Network Jul 2019 - Sep 2019

§ Designed a robust regulatory strategy per guidelines and regulations outlined by US FDA and EU for a Class II neonatal incubator

§ Reconducted research analysis to identify predicate devices, prepared SE table & prepared response to question from agency

§ Delivered a concise Pre-submission template that is easier to file in order to initiate conversation with FDA through Q - Sub meeting

§ Supported & maintained 510K sections including Form FDA 3514, 510k statement, IFU statement & SE discussion

§ Assisted project team in identifying EU Technical Documents for CE Mark to Notified Body & its application review process

§ Validated infant incubator for portable & stationary use, phototherapy, heat & humidity, ventilation, data collection & security Advanced Skills: Q Sub Package, 510K submission, EU CE Mark, ISO 13485, IEC 60601, Notified Bodies CERTIFICATIONS

§ Artificial Intelligence in Healthcare Specialization (Stanford University) Mar 2021 - Ongoing Learning AI based collection of Clinical Data, best practices for designing & building machine learning applications in medicine & healthcare, AI deployment in Healthcare & evaluating AI healthcare solutions, AI in Healthcare Capstone Project

§ Good Clinical Practice for Clinical Trials of Investigational Devices (CITI Program) Feb 2021 - Mar 2021 Developed understanding of IDE, Investigator responsibilities, CTA, Monitoring, Audits, UADE Reporting

§ Practical Regulatory Affairs 2020 - European Medical Device Regulation (Udemy) Dec 2020 - Jan 2021 EU MDR 2017/745, Key Changes to MDR, QMS, Annex VIII, Technical Documentation Overview, GSPR, EUDAMED, Post-Market Surveillance, Notified Bodies and CE Marking Procedures

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