Pratyesh Somani

About Pratyesh Somani

I am a Regulatory Affairs and Quality Assurance professional with 15+ years of experience specializing in Class IIa, IIb, and Class implantable/non-implantable medical devices, with a focus on cardiovascular implants. Currently serving as Manager QA RA at Purple MicroPort Cardiovascular, I lead global regulatory submissions, compliance activities, and post-market surveillance for high-risk devices.My expertise spans ISO 13485:2016, EU MDR 2017/745, and Medical Device Rules 2017, with proven success in managing regulatory audits, handling CDSCO and Notified Body interactions, and acting as Management Representative (MR) and Person Responsible for Regulatory Compliance (PRRC).I have led the development, review, and maintenance of Technical Documentation, Clinical Evaluation Reports (CER), PMS and PMCF activities across multiple centers in India. With strong project ownership and cross-functional collaboration, I bridge regulatory expectations with product innovation and speed to market.I believe in strategic compliance - not just meeting regulations but enabling business goals. My leadership style is collaborative, quality-driven, and focused on continuous improvement. I am passionate about contributing to the advancement of life-saving technologies that enhance patient outcomes globally.

Experience

1. Manager Qa Ra

   Purple Microport Cardiovascular

   Mar 2023 — Present · Surat, IN

   Lead regulatory submissions and product approvals for India, EU, and other global markets- Develop and implement regulatory strategies aligned with company goals and regional requirements- Serve as primary liaison with CDSCO, Notified Bodies, and EC Representative to facilitate approvals- Maintain compliance with ISO 13485, EU MDR 2017/745, and Medical Device Rules 2017- Oversee Post-Market Surveillance (PMS), Post Market Follow-up (PMCF) Clinical Evaluation Reports (CER), and Risk Management Files- Act as Management Representative (MR) and Person Responsible for Regulatory Compliance (PRRC)- Support internal and external audits; lead responses and CAPAs to ensure ongoing compliance- Advise cross-functional teams on regulatory impact of design, manufacturing, and labelling changes- Track and analyze global regulatory updates to ensure timely strategy adaptation.

Education

• Sunflower High School

  Higher Secondary Education, Science

  1999 — 2001

• Veer Narmad South Gujarat University, Surat

  Bachelor of Pharmacy, Pharmacy

  2003 — 2007

• Veer Narmad South Gujarat University, Surat

  Master in Pharmacy, Quality Assurance

  2007 — 2009

Skills

• Purified Water System Validation
• Ce Marking Requirements
• Smf
• Iso 9001
• Dossier Preparation
• Iso
• Pharmaceutical Industry
• Sop
• Deviation Management
• Fda
• Brand Registration
• Oos
• Tmf
• Regulatory Audits
• Export Registration
• Qms
• Internal Audit
• Gmp
• Change Control
• Regulatory Affairs
• Validation
• Dmf
• Corrective and Preventive Action (Capa)
• Quality System
• Labeling and Ifu
• Management
• Medical Devices
• Capa
• Autoclave Validation
• Bmr Handling
• Regulatory Requirements
• Documentation
• Iso 13485
• Hvac Validation
• Quality Auditing
• Eto System Validation
• Technical Master File
• Regulatory Submissions
• Product Registration
• Quality Assurance