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Home
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Jobs in dhaulpur
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Swear Healthcare
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Job Opening Sr Manager Regulatory & Quality Assurance

Job Opening Sr Manager Regulatory & Quality Assurance

Swear Healthcare

10 - 15 years

10 - 12 Lacs

dhaulpur

Posted:1 hour ago| Platform:

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Skills Required

cdsco capa qms

Work Mode

Work from Office

Job Type

Full Time

Job Description

Position Sr Manager – Regulatory & Quality Assurance

Experience – Min 10yrs

Qualification –

Location – Dhaulpur

Salary – Negotiable

In case interested kindly share your resume tohrcorporate@swearhealthcare.com

OR Whats app – 8527517739

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 15223-1, 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.

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