Soumitra Shilotri

About Soumitra Shilotri

My name is Soumitra Girish Shilotri. I am currently working as a Principal Regulatory Affairs with Cardinal Health Medical Devices. I have Masters in Regulatory Affairs; Masters in Project Management and I am currently pursuing Masters in Business Administration (MBA).Highly analytical and results-oriented professional with 10 years plus of experience in Regulatory, Quality & R&D, with proven skills in working within the medical devices & drug industry; complemented with strong knowledge of regulatory product development and product life-cycle management.Strong business and regulatory experience working on various Surgical platforms including Sutures, Surgical Staplers, Clip Appliers, Trocars, Vascular, Ligation, Energy devices that are used in wide variety of Open and Minimally Invasive Surgical Procedures. Adept at providing regulatory intelligence to support the operational and tactical regulatory contribution and direction to various surgical product families throughout their product life-cycle. Known for strong technical writing, providing support to cross functional teams in strategic planning for CE marked product release, international registrations, dossier submissions and leadership skills in solving complex problems and directing cross-functional teams to achieve set goals.I am targeting Regulatory Affair jobs in the medical device industry in US/Canada. I would appreciate the chance to discuss my qualifications and job requirements in more detail. Please feel free to contact me via LinkedIn or email.Thank you for your time and consideration.Best regards,Soumitra G. S••••••••@gmail.com

Experience

1. Principal Regulatory Affairs Specialist

   Cardinal Health

   Jan 2020 — Present · MA, US

   Lead the preparation, submission and maintenance of global product registrations with focus on 510(k), PMA, Technical Files, Design Dossiers. Collaborate with internal Cardinal International regulatory departments to access international registration requirements, develop international regulatory strategy, and ensure timely execution. Review design control documents including documents associated with design inputs and design outputs for regulatory compliance. Review product labeling for compliance with global labeling regulations. Review advertising and promotional literature for compliance with applicable regulations. Interpret and evaluate proposed regulations and advice on impact of such regulations on the business Compilation of Technical Files in accordance with new EU Medical Device Regulation. Review of Clinical Evaluation Reports in accordance with new EU Medical Device Regulation. Lead Regulatory Team effort for MDR Technical Documentation Readiness. Maintain Regulatory Intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies.

Education

• University of Mumbai

  Bachelor's degree, LIFE SCIENCES

  2002 — 2006

• Harrisburg University of Science and Technology

  Master of Science - MS, Project Management

  2017 — 2020

• Trine University

  Master of Business Administration - MBA

  2020 — 2023

• Massachusetts College of Pharmacy and Health Sciences

  Master of Science (MS), Regulatory Affairs and Health Policy

  2014 — 2016

• SIES Graduate School Of Technology

  PGD, Biotechnology

  2006 — 2007

Skills

• Negotiation
• Communication Skills
• 21 Cfr Part 11
• High Organizational Skills
• Formulation
• Regulatory Requirements
• Ind
• Self Management
• Vaccines
• Microbiology
• Life Sciences
• Written & Oral Presentation Skills
• Biotechnology
• Strong Business Acumen
• Pharmaceutical Industry
• Sop
• Clinical Development
• Fda
• Validation
• Documentation
• Persuasion
• Oncology
• Clinical Trials
• Interpersonal Skill
• Medical Devices
• Clinical Research
• Capa
• Teamwork
• Drug Development
• Ectd
• Problem Solving
• Glp
• Hplc
• Positive Can-Do Attitude
• Molecular Biology
• Pharmacovigilance
• Quality Control
• Gmp
• Pharmaceutics
• Time Management