Job Opening Sr Manager Regulatory

Position Sr Manager – Regulatory & Quality Assurance

Experience – Min 10yrs

Qualification – Graduate or Post Graduate (B.SC./M.Sc./M. Pharma) in Life Science / Chemistry.

Location – Dhaulpur

Salary – Negotiable

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Roles & Responsibilities

• Responsible for implementation of Quality Management System as per ISO 13485:2016.
• Knowledge of BIS-ISI product registration & renewals.
• Understanding of UDI labeling requirements, UDI processes & Product Labeling to meet the GS1, ISO , EN 62366, ISO 20417, and EU MDR 2017/745 requirements, etc. Knowledge of barcode symbology (GS1 barcodes, & QR codes, etc.)
• Responsible for maintaining the Technical Documentation as per EU MDR 2017/745.
• Coordinating with the Notified Body for EU MDR 2017/745 and ISO 13485 Audits.
• Coordination with the CDSCO and State Licensing Authority for MD-5 Manufacturing License, Import License, Neutral Code, Non-conviction Certificate, Marketing Standing Certificate, Free Sale Certificates, and QMS Certificate.
• Planning & scheduling the Internal & External Audits for ISO 13485 & EU MDR 2017/745.
• ISO 13485 Lead Auditor or Internal Auditor.
• Strong knowledge of Medical Device Regulations as per Indian Medical Device Rules 2017, EU MDR 2017/745, and other Global regulatory requirements.