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Medical Device Documentation Specialist

1 week ago


Mumbai, Maharashtra, India Seloi Healthcare Pvt Ltd Full time
About Seloi Healthcare Seloi Healthcare is a leading name in the diagnostic industry, committed to manufacturing top-quality in-vitro diagnostic products with our motto: "To provide the best healthcare for human welfare."

We specialize in producing diagnostic kits and systems used in hospitals, blood banks, clinics, and laboratories worldwide. With a focus on continuous improvement, we ensure every test meets the highest standards, as we understand its critical role in human life. Job Summary Seloi Healthcare is looking for a detail-oriented Medical Device Documentation Specialist

to manage regulatory, technical, and quality compliance documents for our in-vitro diagnostic products. Key Responsibilities · Prepare and review documentation for medical devices, ensuring compliance with international regulations. · Work with regulatory teams to submit documents for product approvals. · Maintain technical files, risk assessments, and quality management system (QMS) documentation. Requirements · Experience in medical device documentation or regulatory affairs. · Familiarity with ISO 13485, CE marking, and FDA regulations . · Strong attention to detail and writing skills.