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20 Healthium Medtech Jobs
Documentation Support
Healthium Medtech
posted 2mon ago
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Flexible timing
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Job Description
- New Product Development : Collaborating in cross-functional teams for new product development and approvals, including acquiring test licences from domestic and international bodies.
- Regulatory Approvals : Managing manufacturing licences for importing products and ensuring compliance with regulatory requirements for product launches.
- Supplier and Audit Management : Overseeing supplier qualification and conducting site audits in domestic and international markets.
- Production and Compliance Support : Assisting in transferring new products to production facilities while ensuring regulatory compliance.
- Design and Quality Documentation : Reviewing design documentation for quality attributes like manufacturability, serviceability and reliability, per organisational standards.
- International Regulatory Compliance : Managing submissions and addressing changing requirements for international regulatory approvals, including communication with customers and local agents.
- Market Registration : Registering HML products in expanding global markets and supporting Own Brand Labellers (OBL) for HML sites.
- Regulatory Tasks : Handling tasks related to State and Central Drugs Control Departments, especially for imported and outsourced products.
- Documentation Support : Providing necessary documents (FSCs, certificates, etc.) for international business and clients.
- Standards Expertise : Familiar with ISO 9001, ISO 13485, IEC 62304, ISO 14971, 21 CFR Part 820, 21 CFR Part 11, EU MDR, UKCA, USFDA and product-specific industry standards.
- Regulatory Filings: Preparing and submitting 510(k) and PMA filings for registered products.
- Client Certifications : Supporting clients for product certifications in various countries, working with local agents and customer-facing managers.
- Country-Specific Submissions : Managing regulatory submissions in ASEAN, EU MDR, US, TFDA, SFDA, NVISA, COFEPRIS and other ROW countries as per local requirements.
Employment Type: Full Time, Permanent
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