Posted:1 hour ago|
Platform:
On-site
Full Time
Key Responsibilities:
1. Design History File (DHF) Preparation and Technical File Compilation for Notified Body Submission
· Compile and maintain DHF documentation as per ISO 13485 and FDA 21 CFR Part 820 requirements.
· Support preparation of EU MDR (2017/745) technical files, including General Safety and Performance Requirements (GSPR) checklist.
· Ensure alignment with ISO 11608, ISO 11040, and other applicable standards for drug–device combination products.
· Support creation of Threshold Analysis Reports and justification in line with FDA guidance.
4. Risk Management
· Creation and maintenance of Risk Management Files (RMF) as per ISO 14971:2019.
· Identify potential hazards, evaluate risk control measures, and prepare FMEA tables.
5. Device Development & Combination Product Documentation
· Support preparation of design documentation for drug–device combination products such as pre-filled syringes, pen injectors, autoinjectors, and IV systems.
· Collaborate with cross-functional teams to capture development data, component specifications, and testing results.
Job Types: Full-time, Fresher
Pay: ₹10,000.00 - ₹13,000.00 per month
Work Location: In person
3i Concept Medical Device Solutions
Upload Resume
Drag or click to upload
Your data is secure with us, protected by advanced encryption.
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
We have sent an OTP to your contact. Please enter it below to verify.
Instantly access job listings, apply easily, and track applications.
chennai
6.7 - 8.0 Lacs P.A.
Experience: Not specified
1.2 - 1.56 Lacs P.A.
Experience: Not specified
4.325 - 7.2 Lacs P.A.
chennai, tamil nadu, india
Salary: Not disclosed
chennai, tamil nadu, india
Salary: Not disclosed
gurugram, haryana, india
Salary: Not disclosed
pune, maharashtra, india
Salary: Not disclosed
navi mumbai, maharashtra, india
Salary: Not disclosed
hyderabad, telangana, india
Salary: Not disclosed
chennai, tamil nadu, india
Salary: Not disclosed
