---
title: "Vaishak R S - Quality Analyst in Chennai | Tal"
description: "Meet Vaishak R S, R&D Regulatory Affairs Specialist (Medical Device), EU MDR 2017/745 | FDA 21 CFR Part 820 | ISO 13485 | ISO 14971 | ISO 11607 | Labeling & Packaging | QAQC | CAPA | Compliance Handling | Risk Management based in Chennai. AI stack includes claude code, openai, and Adobe Firefly."
image: "https://tal.club/meet/vaishak-rs/share-image"
---

# Vaishak R S on Tal

## Headline

R&D Regulatory Affairs Specialist \(Medical Device\), EU MDR 2017/745 \| FDA 21 CFR Part 820 \| ISO 13485 \| ISO 14971 \| ISO 11607 \| Labeling & Packaging \| QAQC \| CAPA \| Compliance Handling \| Risk Management

## About

Experienced Regulatory Affairs Specialist in the field of medical devices with a strong track record of ensuring compliance and driving successful EU MDR & UK MDR, Labeling design, complaints handling and change management projects with 4 years of dedicated industry experience, I am passionate about navigating the ever\-evolving regulatory landscape to bring innovative healthcare solutions to market\. My expertise lies in interpreting and implementing MDR requirements, collaborating cross\-functionally, and delivering on\-time, quality submissions\. Let’s connect to discuss how my skills can contribute to your team’s success in achieving regulatory excellence and product safety in the medical device industry\.

## Location

Chennai

## AI stack

claude code

openai

Adobe Firefly

ChatGPT

## Work experience

Quality Analyst at ICU Medical, Nov 2025 \- Present · 11 mos, Chennai, Tamil Nadu, India

Senior Process Associate at GENPACT, Jan 2025 \- Jun 2025 · 6 mos

Regulatory Specialist at HCLTech, Oct 2022 \- Jan 2025 · 2 yrs 4 mos, Chennai, Tamil Nadu, India, Project: EU MDR Remediation \(Specialty Gap Assessment\): • Hands on experience in change control management, particularly in handling material/design changes, and supplier changes\. • Experience in performing Design History file \(DHF\) remediation taszzks, preparing DHF Indexes and conducting DHF reviews to ensure its compliance as per guidelines\. • Possess understanding of both pre and post submission notified body activities, including updates related to deficiencies based on notified body comments\. • Familiar in writing the technical documents, Clinical Evaluation and Post Market Surveillance data concerning to a medical device\. • Familiarity with various PLM tools associated with the project\. • Possess knowledge on various methods of sterilizations \(like \- EO Sterilization, Radiation Sterilization, and Steam Sterilization\) and its validations\. • Possess Knowledge in the various test methodologies for validating the packaging of a medical device\. • Performed EU MDR Gap assessment as part of Remediation activities in terms of Sterilization & Packaging for various medical devices as per ISO 11607\. • Handling the team with quality aspect as a Defect Prevention Analyst, and as a Configuration Controller\. • Having knowledge in EU MDR 2017/745, ISO 13485, ISO 14971, ISO 11607, and ISO 14644\. • Discussing on the queries and continuous improvement points with the stake holders\.

## Education

Bachelor of Technology \- BTech, Mechanical Engineering, SRM IST Chennai

[View the original profile](https://tal.club/meet/vaishak-rs)

```json
{
  "@context": "https://schema.org",
  "@graph": [
    {
      "@type": "Person",
      "@id": "https://tal.club/meet/vaishak-rs#person",
      "name": "Vaishak R S",
      "url": "https://tal.club/meet/vaishak-rs",
      "image": "https://tal.club/meet/vaishak-rs/profile-photo.jpg",
      "description": "Meet Vaishak R S, R&D Regulatory Affairs Specialist (Medical Device), EU MDR 2017/745 | FDA 21 CFR Part 820 | ISO 13485 | ISO 14971 | ISO 11607 | Labeling & Packaging | QAQC | CAPA | Compliance Handling | Risk Management based in Chennai. AI stack includes claude code, openai, and Adobe Firefly.",
      "jobTitle": "Quality Analyst",
      "worksFor": {
        "@type": "Organization",
        "name": "ICU Medical"
      },
      "hasOccupation": {
        "@type": "Occupation",
        "name": "Quality Analyst"
      },
      "homeLocation": {
        "@type": "Place",
        "name": "Chennai"
      },
      "alumniOf": [
        {
          "@type": "EducationalOrganization",
          "name": "SRM IST Chennai"
        }
      ],
      "knowsAbout": [
        "claude code",
        "openai",
        "Adobe Firefly",
        "ChatGPT"
      ],
      "mainEntityOfPage": {
        "@id": "https://tal.club/meet/vaishak-rs#webpage"
      }
    },
    {
      "@type": "ProfilePage",
      "@id": "https://tal.club/meet/vaishak-rs#webpage",
      "url": "https://tal.club/meet/vaishak-rs",
      "name": "Vaishak R S on Tal",
      "description": "Meet Vaishak R S, R&D Regulatory Affairs Specialist (Medical Device), EU MDR 2017/745 | FDA 21 CFR Part 820 | ISO 13485 | ISO 14971 | ISO 11607 | Labeling & Packaging | QAQC | CAPA | Compliance Handling | Risk Management based in Chennai. AI stack includes claude code, openai, and Adobe Firefly.",
      "dateModified": "2026-09-22T03:30:51.398Z",
      "isPartOf": {
        "@id": "https://tal.club/#website"
      },
      "mainEntity": {
        "@id": "https://tal.club/meet/vaishak-rs#person"
      },
      "primaryImageOfPage": {
        "@type": "ImageObject",
        "url": "https://tal.club/meet/vaishak-rs/profile-photo.jpg",
        "contentUrl": "https://tal.club/meet/vaishak-rs/profile-photo.jpg",
        "caption": "Vaishak R S profile photo on Tal"
      },
      "inLanguage": "en-IN"
    }
  ]
}
```