Young Technological Professional (YTP-Regulatory)

Effibar Cds; New Delhi; Sur place; INR 650 000 - 1 000 000; Plein temps

Résumé du poste

Effibar Cds is seeking a Young Technological Professional (YTP-Regulatory) in Delhi, India. The role focuses on regulatory affairs, dossier drafting, and ensuring compliance across MDR-2017, NDCT-2019, QMS, and ISO standards. Fluency in Hindi and English is expected, with strong MS Office skills.

The candidate will draft regulatory dossiers, support internal audits, and participate in clinical performance evaluation activities, ensuring quality and regulatory compliance across GMP/GLP frameworks.

Qualifications

• Knowledge of MDR-2017, NDCT-2019, QMS, GLP, GMP.
• Drafting dossiers and responding to regulatory queries.
• Understanding ISO 9001, ISO 13485, ISO 14971, IEC 62304.

Responsabilités

• Draft regulatory dossiers per requisite checklist and respond to queries.
• Support internal audits, quality control and QA processes.
• Assist in clinical performance evaluation/investigation activities.

Connaissances

Regulatory knowledge

Dossier drafting

Quality systems

Clinical evaluation

Audits

MS Office

Outils

MS Office

Description du poste

Name of the Position: Young Technological Professional (YTP-Regulatory)

Technical knowledge of MDR-2017, NDCT-2019, QMS, GLP, GMP

Drafting of dossier as per the requisite checklist and queries responses against the regulatory application

Well versed in handling regulatory matters & providing necessary support in internal audits, quality control, quality assurance, clinical performance evaluation/ clinical investigation/performance evaluation etc.

Sound comprehension of compliances as per ISO 9001, ISO 13485, ISO 14971, IEC 62304 etc.

Organizing expert committee meeting with strong communication skill (Hindi, English)

High proficiency in Microsoft package (word, excel, ppt, graph, designing, etc.)