Overseas Production Cooperation Development Manager
15 hours ago
Location - New Delhi.
Overseas Production Cooperation Development Manager
This role focuses on identifying overseas partners for joint factory establishment, addressing three core requirements: regulatory compliance, technology transfer, and localized production. It covers the entire process from partner selection to factory commissioning, with the goal of realizing localized production through cooperative factory building.
Core Responsibilities
Accurate Partner Selection and Qualification Verification
Capacity and Technology Compatibility Assessment: Conduct research on potential partners in target markets, focusing on verifying whether they possess the production capabilities for the corresponding product categories.
In-depth Compliance Qualification Review: Verify if partners hold mandatory certifications required by the target market (such as EU CE certification, US FDA registration, and Middle East GCC certification) and if they have obtained ISO 13485 quality management system certification. This avoids product launch failures due to lack of qualifications.
Regulatory Adaptation and Technology Transfer Implementation
Local Regulatory Alignment: Research specific requirements of the target country, and assist partners in updating factory qualifications and completing product registration.
Technical Standard Dissemination: Convey core production processes to partners, provide assembly manuals for SKD/CKD (Semi-Knocked Down/Completely Knocked Down) parts, and coordinate the headquarters technical team to provide on-site guidance. Ensure product quality is consistent with that of the original factory.
Business Negotiations and Cooperation Model Design
Flexible Customization of Cooperation Plans: Design cooperation models based on product characteristicssuch as the "CKD full knocked-down parts + technology licensing" model or the "SKD semi-knocked-down parts + OEM production" model—to balance technology protection and cost control.
Risk Prevention in Core Terms: Clarify the division of quality responsibilities, intellectual property protection, and joint liability for compliance.
Factory Establishment Implementation and Localized Operation Support
End-to-End Control of Production Preparation: Assist partners in completing factory layout planning, equipment selection, and personnel training.
- Supply Chain Coordination and Assurance: Establish a delivery schedule for parts, coordinate with customs to complete classified declaration of medical device parts, and avoid production delays caused by customs clearance hold-ups.
Recruitment Requirements
- At least 5 years of experience in international medical device business.
- Familiar with FDA/CE certification processes.
- It is also necessary to understand the local regulatory requirements regarding medical device certification, registration, and other relevant aspects.
- Capable of independently completing qualification assessment of overseas cooperative factories and technology transfer.
- Priority will be given to candidates who have led SKD/CKD cooperation projects.
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