510 (K), 21 CFR 820, 803, Medical Device Reporting, Regulatory Strateg

Versatile Regulatory Affairs Professional with *+ years regulatory & project management experience in life science domain.

Core Skills and Competencies

Verbal & Written Communication

Project Management

Attention to Details

Analytical & Rigorous Problem Solving

Microsoft Office (Excel, power point etc.)

Organizational skill

Regulatory writing

Medical Device Reporting

21 CFR 803, 820 QSR

510 (k) Submission

Pre-Market Application

Professional Experience

LiLu, Inc, PA, USA

Intern, Regulatory Affairs Apr 2018 – Jun 2018

Identified & Prioritized potential market for commercialization in Asia-Pacific region byconducting market & regulatory hurdle analysis.

Interpreted major regulatory and administrative hurdles for market access in Australia, India, and New Zealand.

Prepared in-depth report and advised on regulations applicable for maternal health device approval by TGA, MedSafe, & CDSCO.

Analysed regulatory requirements including determination of medical device classification, establishment & registration licenses (essential principles, conformity assessment, DEAL submission, GMDN code and terms) for Australia, India, and New Zealand.

Developed a regulatory strategy & pathway for proposed maternal health device approval by TGA, MEDSAFE, and CDSCO, led to reduce regulatory burden by 50% and financial requirements by 60%.

Assisted in preparation of regulatory file documents like Essential principles, Declaration of Conformity, pre-submission meeting.

Medtronic & Cardinal Healthcare, Mansfield, MA, USA

Post-Market Surveillance Specialist Jul 2017 – April 2018

Evaluated more than 12,000 medical device complaint information working on Global Complaint Handling (GCH) system.

Determined reportability(MDR/AE) of complaints to the FDA in accordance with business procedures, 21 CFR 803 & 820.198 and other international regulatory agencies.

Ensured complaint files are complete through reassessment and in compliance with regulatory requirements prior to closure.

Coordinated with cross-functional teams for timely investigation, escalation, and closure of complaints.

Interacted with internal/external departments and customers for additional information and quality processing of complaints.

Delivered training to 12 members on complaint intake, coding of events, and reportability determination through decision tree.

Participated in a weekly meeting to discuss and provide input on process and quality improvement.

Savli Technology Bio-Incubator, Gujarat State Biotechnology Mission- Gandhinagar, India

Incubation Associate/Manager Apr 2015 – Aug 2016

Managed a Technology Business Incubator & facilitated 6 life-science research projects by effective planning & implementation.

Prepared detailed regulatory requirement report for obtaining approval of medical device product in European Union & India.

Represented the organization and state at various national/international biotech conferences/exhibitions.

Designed & implemented two programs (The Idea Doodle Lab, IP Clinic) to test proof of concept of innovative medical devices & biotech/pharmaceutical products.

New Royal Chemist- Mumbai, India

Sr. Pharmacist & Management Executive Jul 2011 - Feb 2015

Led a team of nine members in a prescription drug dispensing unit to oversee the dispensing activity in accordance with regulatory guidelines and FD& C Act.

Contributed to vertical and horizontal business expansion activity and obtained establishment registration and licenses for two new pharmacy units in accordance with FD & C act requirements.

Formal Education

Master of Science in Regulatory Affairs in Drugs, Biologics and Medical Devices GPA 3.96 Sept 2016 - Jul 2018

Northeastern University, Boston, MA

Related Coursework: Introduction to Drug and Medical Device Regulations, Medical Device Development: A Regulatory Overview, Canada, Asia, Latin America - Medical Device Regulatory Overview, A Biologics Development: A Regulatory Overview, Strategic Planning and Project Management for Regulatory Affairs, Regulatory Writing, Global Biotech Development, New Drug Development.

Bachelor of Pharmacy GPA 3.49 Aug 2009 - Jul 2011

NMIMS University, Mumbai, India

Related Coursework: Quality Assurance & Regulatory Affairs, Good Manufacturing Practices (GMP), Drug Design, Pharmacology, Pharmaceutics, Novel Drug Delivery System, Medicinal Chemistry, Clinical Pharmacy.

Diploma in Pharmacy Aug 2007 - Jul 2009

Maharashtra State Board of Technical Education, Mumbai, India,

Registered Pharmacist, Pharmacy council of Maharashtra, India Nov 2011

Academic Project work

Due -diligence of regulatory documents for partnering with small size pharmaceutical company having new molecule in phase-I clinical trials.

Determination of medical device class, identification of predicate device and appropriate regulatory submission pathway, applicable documents and fees for REBOA catheter marketing approval in the United States.

A comparative analysis of device classification system, regulatory pathways for device registration, submission/documentation requirements, review and approval time line in Taiwan, Australia, and Mexico.

Interpretations of regulations & Documents applicable to 510 (k) submission process to FDA for Class-II medical devices.

Preparation of labelling for recently approved Biologic product Durvalumab in accordance with 21 CFR 610 subpart G.

Designing of label including Unique Device Identification of PEEK SPACER SYSTEM based on IMDRF and industry standard methodologies.

Other Skills and knowledge: US FDA regulations EU Directives EU MDR MDSAP CE Mark TGA ARTG eCTD Medical device regulatory system of Singapore, Latin America, Canada, India, Australia Unique Device Identifier (UDI) Clinical Studies IRB HDE

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