Resume

1+ years of experience supporting design of regulatory strategies, Q-sub meeting documents, preparing FDA compliant dossiers and preparation of eCTD – compliant dossiers for submission to health authorities in the US, EU, China, and Japan. Professional experience includes preparation of Informed Consent Form, Clinical Protocol, IDE, IFUs, Market Analysis Report and Reimbursement strategy in multiple therapeutic areas and product types for medical devices spans multiple therapeutic areas and product types, including drugs, biologics, and medical devices. Ambitious, detail-oriented, dedicated professional with demonstrated ability to effectively collaborate in a matrix environment. Demonstrated success in problem solving. Academic experience in Pre and Post marketing safety reporting for FDA and EMA, 510(k), Regulatory Business Strategy, Pre and Post marketing safety reporting for FDA and EMA, CAPA for Warning letters and REMS. Proficiency in Regulatory Intelligence for Cosmetics and Predicate devices.

Summary

Innovative and deadline-driven Regulatory Affairs Professional with 1+ years of experience designing and developing Regulatory Product Development profile from initial concept to final, polished deliverable.

  • Boston, MA
  • patel.shan@northeastern.edu

Education

M.S. in Regulatory Affairs

2019 - 2021

Northeastern University, Boston

Relevant Courses: Medical Device and Pharma Regulations for the US, Medical Device strategy for various markets, Legal Issues in the EU for Medicinal Products and Drugs, Human Experimentation and safety reporting in clinical trials

Bachelor's in Pharmacy

2014 - 2018

Gujarat Technological University, India

Relevant Courses: Quality Assurance, Biopharmaceutics, Pharmacokinetics, Novel Drug Delivery Systems, Formulation, Development, and Design, Pharmacology, Medicinal Chemistry, Phytopharmaceuticals, Pharmaceutical Biotechnology, Microbiology.

Skills

Medical Device Skills

510(k), PMA, PMA Supplements, IDE, HDE, 21 CFR 812

Clinical Skills

GLP, GCP, Informed Consent Forms, 21 CFR 50, 54, 56 and 312, Clinical Study Protocols

Quality Management

QMS, CAPA, ISO 9001, ISO 13485, ISO 14971, 21 CFR 820

General Regulatory

IND, NDA, ANDA, BLA, eCTD, EU MDR 2017/745, Directive 93/42/EEC and 98/79/EEC

Safety Submisson

FMEA, MedWatch, IB, FAERS, ICSRs, CFR 314.80, Signal detection, PBRER/PSUR, DSUR, MAUDE

Technical

Microsoft Office, Adobe Acrobat, Slack, Asana

Professional Experience

Regulatory Intelligence Intern

01/2021 - Present

China Med Devices - Andover, MA

  • Collected regulatory submission information for ASEAN countries – Japan, Australia and India and compared regulatory submission and life cycle requirements with EU MDR 2017/745
  • Prepared detailed map and process of each defined countries key requirements and authorities responsible for regulatory approval
  • Collaborated in teams to create a comparison table of key Technical and clinical submission requirements, fees and pathways for submissions in each country
  • Composed life cycle development and regulatory approval detailed information for EU, Australia, Japan and India medical device regulation including ISO 14155:2011 and ISO 13495:2013 requirements in submission
  • Understood Global Harmonization efforts for each country including post marketing requirements
  • Helped sponsor to make decision, the company should expand its regulatory and clinical affairs services to other Asia key countries such as Japan, Korea, Australia, India

Regulatory Associate, Medical Devices Intern

09/2020 - Present

Breegi Scientific - Brookline, MA

  • Prepared Regulatory Reimbursement Strategy for US to provide a rationale on Medical Device reimbursement and Target payor Breegi could target for reimbursement
  • Delivered detailed reimbursement methods, process flow, ICD Codes and inpatient and outpatient setting for reimbursement parties in Microsoft PowerPoint
  • Analyzed market data to predict incubator market in Asia-Pacific region and created a NICI market analysis in MS Power point
  • Worked in teams to prepare Q-sub for an infant Incubator – NICI
  • Researched secondary predicate device to match NICI’s IFU and compiled questions to be cleared for the device dossier from the FDA
  • Collected information for Turkey Medical Device regulations from Turkish Medicines and Medical Devices Agency (TMMDA)
  • • Worked in teams to gather import and export regulations and EU/CE marking incentives for Neonatal Incubator – NICI

Regulatory Affairs Associate Intern

03/2020 - 09/2020

Global Regulatory Partners - Waltham, MA

  • Helped with creating dossiers for Drugs, Biologics and Medical Devices for US submissions
  • Collaborated with regulatory experts and gained familiarity with GAP Analysis for DH3 (HPV detection kit)
  • Assisted in filing IFU for Dalton Bioscience in the US for DH3
  • Generated Q-Sub request for an IDE submission of Hollow Fiber Dialyzer for Bain Medical Equipment
  • Reported progress and interacted with client companies every week to provide information relating to the submission
  • Drafted regulatory requirements, standards, classification, sterility testing, classification and quality requirements in MS Excel for PPE for US and EU
  • Edited and formatted QMS and Manufacturing information, Volume IV dossier for Da Vinci Xi device for SS Innovation
  • Assisted in preparing Clinical Trial Protocol for Nucleic Acid Detection kit – DH3 (HPV) for Dalton Bioscience
  • Reviewed packaging performance at different temperatures with sampling plan for bacterial endotoxin for Volume 4 for IDE application
  • Worked in cross – functional collaboration with regulatory experts to prepare Module 3 of the IND submission
  • Reviewed and edited an IND application of SLYVANT for treatment of COVID-19 for EUSA Pharma
  • Reviewed Module 3 (Quality) and 5 (Clinical) of NDA for 9 different cold kits for Curium Pharma
  • Helped compiling NDAs for Striascan, Tc 99m Sestamibi injection, Pulmotech MAA, Technescan HDP, Technescan V4, Ultratag RBC and Sodium I-123
  • Collaborated with regulatory departments of Curium Pharma to review Quality specifications for Cold kits
  • Helped report progress and interacted with client every week to provide information relating to NDA submission for cold kits
  • Assisted in Clinical Trial Protocol for Nucleic Acid Detection kit for Dalton Bioscience in the US
  • Prepared aim, background, research site, inclusion and exclusion criteria for Phase II clinical protocol for checking clinical accuracy of cervical cytology in ASC-US and evaluating clinical effect of the detection kit for first line screening in women

Regulatory Intelligence Intern

09/2019 - 12/2019

Freyr Solutions - Princeton, NJ

  • Evaluated and assessed cosmetic ingredients across various countries in effective regulatory analysis
  • Incorporated IFUs, ingredient CAS no., INCI name, ingredient synonym, labeling requirements and safety considerations in an MS Excel document
  • Used Feedly, EUCosing and PubMed to derive information for US, EU, Australia and India to filter cosmetic restricted ingredients in different regions
  • Extracted country-wise regulatory information to facilitate cosmetic ingredient restriction/prohibition in US, EU, Australia and India in MS Excel
  • Reported ingredient identity, functions, regulatory status, limits/ranges, restrictions/prohibitions and labeling for effective marketing of cosmetic ingredients
  • Supported compliance with FDA’s Consumer Commitment Code and Regulation (EU) 655/2013 cosmetic regulations to comply with quality and safety factors for cosmetic ingredients