Job Description

Responsible for planning, executing, and overseeing pre- and post-market clinical studies for medical devices in compliance with CDSCO, EU MDR, ISO 14155, ICH-GCP, and NDCT-2019. Leads clinical strategy, protocol development, site and investigator management, regulatory submissions (CER, PMCF, CSR), and ensures robust clinical evidence generation to support regulatory approvals and post-market surveillance.
Key Responsibilities / Skills:
Clinical strategy development and study execution
CER, PMCF, PMS, and CSR preparation
EC & CA submissions and regulatory support
Site initiation, monitoring, and close-out
Strong knowledge of ISO 14155, ICH-GCP, ISO 13485, ISO 14971
Excellent scientific writing and stakeholder management
Skills Cco, Clo, Coo, Cro, Biotech, Product Design, Stakeholder Management, Inspection, Pharma, Education, Erp, Risk Management, Visio, Quality Systems, Data Management, Compliance, Pivotal, Data Interpretation, Leadership, Biostatistic, Excel, Pharmacy, Financial Management, Biotechnology, Detail-oriented, Patient, Documentation, Seo, Supervision, Budgeting, Technical Skill, Technical Skills

Skills Required