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Medical Device Documentation Specialist
Seloi Healthcare Pvt LtdNashik, IN1 day ago
Job descriptionExperience in medical device documentation or regulatory affairs. Familiarity with ISO 13485, CE marking, and FDA regulations . Strong attention to detail and writing skills.
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