Back to Jobs
Manager – Quality & Regulatory Affairs
Advent Global Solutions
Hyderabad - Secunderabad
Not Disclosed
2 - 4 Years
Full Time - Permanent
Views:266
Applicants:0
Posted on 16 Jun, 2025
In Office
Job Description | Responsibilities
- Lead and maintain the QMS in accordance with ISO 13485 & other relevant global standards
- Ensure compliance with regulatory requirements; FDA QMSR & EU IVDR
- Prepare and manage regulatory submissions such as 510k,CE Marking documentation
- Collaborate with R&D,manufacturing & Clinical teams to ensure quality & regulatory throughout product lifecycle
Overview
- Industry - Other Healthcare Equipments & Supply, PHARMACEUTICAL / MEDICAL DEVICES / CRO
- Functional Area - IT Software Programming / Analysis / Quality / Testing / Training
- Job Role - Software Quality Assurance Manager
- Employment type - Full Time - Permanent
- Work Mode - In Office
Qualifications
- Any Graduate - Any Specialization
- Any Post Graduate - Any Specialization
- Any Doctorate - Any Specialization
Job Related Keywords
Quality Management System
Regulatory Compliance
ISO 13485
FDA QMSR
EU IVDR
510k Submission
Risk Management
Internal & External Audits