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Endo-Med Technologies

Compare

2.0

based on 2 Reviews

1 Endo-Med Technologies Job

Manager- Documentation & Regulatory Affairs

Endo-Med Technologies

2.0

based on 2 Reviews

2-5 years

Noida, New Delhi

1 vacancy

Manager- Documentation & Regulatory Affairs

Endo-Med Technologies

posted 15d ago

Job Role Insights

Flexible timing

Key skills for the job

ESIC Biotechnology Pharmacy Software Configuration Management Biomedical Engineering Legal Advisory

+ 4 more

Job Description

Qualification: B Pharma/ Biotech/ Bio Medical Engineering (Regulatory affair courses/certifications would be value addition)

Experience: 2-5 years of experience of Regulatory Affairs in Medical Devices

Job Description: As a Manager in Regulatory Affairs, you will play a crucial role in ensuring compliance with regulatory guidelines for medical devices. Here are some key responsibilities:

Preparing documentation and market regulatory submissions for medical devices as per MDR-2017
Documentation Management
Submit and follow up on required documentation/information with concerned authorities such as CDSCO, ISO, C.E., USFDA
Ensure the creation of adequate documentation for audits/inspections.
Coordinate and respond to requests from regulatory agencies.
Ensure the timely upload of regulatory submission dossiers
Ensure registration certificates and approvals for manufacturing and import licenses for medical devices.
Support the foreign buyer by providing regulatory documents for registration in their respective countries