Manager Clinical Affairs
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 Required
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Job Detail
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Job IdJD5060710
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationAhmedabad, Gujarat, India
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EducationNot mentioned
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ExperienceYear