Manager - Clinical Research United Hr Solutions

11.0 - 16.0 years

15 - 20 Lacs

ahmedabad

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The Manager Clinical Research is responsible for planning, designing, and managing clinical investigations for medical devices in accordance with CDSCO, EU MDR, ISO 14155, ICH-GCP, and NDCT-2019 requirements. The role ensures generation of high-quality clinical evidence to support product safety, performance, regulatory approvals, and post-market surveillance. Key responsibilities include developing Clinical Evaluation Plans and study protocols, leading pre- and post-market clinical studies (including PMS and PMCF), managing investigators, sites, and CROs, ensuring compliance with global clinical and quality standards, supporting regulatory submissions, and collaborating with cross-functiona...

Posted 1 day ago

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Executive-Quality Assurance & Validation DDI India

3.0 - 5.0 years

4 - 5 Lacs

hyderabad, madhapur, telangana

Work from Office

QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Interfaces with customers and vendors representing company ...

Posted 4 months ago

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Executive-Quality Assurance & Validation DDI India

3.0 - 5.0 years

4 - 5 Lacs

Hyderabad, Madhapur, Telangana

Work from Office

Posted 6 months ago

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