Medical & Regulatory Writer
Job Description
Ensure clinical investigations comply with ISO 14155:2020 and ICH-GCP guidelines.
Oversee regulatory submissions and study approvals in alignment with the New Drugs and Clinical Trials Rules (NDCTR), 2019.
Coordinate biocompatibility evaluations following ISO 10993-1 requirements.
Support risk management activities as per ISO 14971 and ISO 24971.
Prepare and maintain clinical study documentation, protocols, and reports.
Conduct internal audits and compliance checks to ensure adherence to global and local regulatory standards.
Collaborate with clinical teams, regulatory authorities, and ethical committees for study execution and approvals.
Provide training on clinical compliance, regulatory updates, and quality system requirements.
Skills Required
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Job Detail
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Job IdJD4830418
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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