ClinChoice Hiring Regulatory Affairs Associates – Drug Listing & EU MDR Jobs | Bangalore

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ClinChoice Hiring Regulatory Affairs Associates (Drug Listing & EU MDR)

ClinChoice

Bengaluru

2–6 Years

Regulatory Affairs

Drug Listing

EU MDR

Full-Time

📄 About the Company

ClinChoice is a global clinical research and regulatory services organization with operations across US, UK, Europe, and Asia-Pacific.

The company partners with leading pharmaceutical, biotech, and medical device organizations to deliver regulatory excellence, lifecycle management, and patient safety solutions.

📌 Job Overview

ClinChoice is hiring for multiple Regulatory Affairs roles in Bengaluru covering FDA Drug Listing and EU MDR Regulatory Operations.

These positions are ideal for professionals seeking long-term career growth in pharmaceutical and medical device regulatory affairs.

📌 Position 1 – Associate / Senior Associate (Drug Listing)

Location: Bengaluru (Office-based)

Experience: 2–4 Years

Employment Type: Full-Time, Permanent

Execute drug product lifecycle management for North America
Prepare and submit FDA regulatory submissions
Write, review, and submit Drug Listing (DL) documentation
Evaluate and maintain NDC numbers for products
Manage change controls and regulatory impact assessments
Maintain documents in CEDMS, DSP/cMAT, Reg Point & SharePoint
Support Annual Product & Establishment Registration

Eligibility:

Degree in Pharmacy / Life Sciences or related discipline
Hands-on experience with FDA submissions & drug listing

📌 Position 2 – Senior Associate (Reg Ops EU MDR)

Location: Bengaluru (Remote)

Experience: 4–6 Years

Employment Type: Full-Time

Compile & maintain Technical Files / Design Dossiers under EU MDR 2017/745
Identify applicable standards, MDCG guidance & requirements
Perform QC checks on regulatory documents
Create indexed PDFs and upload via PLM Change Orders
Coordinate with affiliates for legal documents (CFS, CFG, etc.)
Represent Regulatory Affairs on cross-functional teams

Eligibility:

Degree in Life Sciences / related field
Strong knowledge of EU MDR, ISO 13485 & medical device regulations

🎯 Why Join ClinChoice?

Global exposure to pharma & medical device regulatory projects
Career growth in Regulatory Affairs & Regulatory Operations
Remote work option available (EU MDR role)
Competitive salary & benefits
Work with international clients & advanced regulatory platforms

📌 Note Before You Apply:
Please carefully select the correct role from the dropdown below before applying. Reading the full job description improves shortlisting chances.

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