Responsibility： 1. Stakeholder Management: 61 Establish and maintain positive relationships with regulatory authorities and industry bodies. Also, being the main contact person for headquarters. 61 Act as the main contact point for audits and inspections by regulatory agencies. 2. Strategic Planning: 61 Contribute to the development of the company’s regulatory strategy and goals by accessing and cooperating with sales, marketing and product management. 61 Provide strategic regulatory input and risk assessments for new product development projects. 3. Regulatory Intelligence: 61 Continuously monitor and assess the regulatory landscape for changes that could impact the company’s products and business operations. By also work on countermeasures with global Engineering and RA. 61 Develop and maintain a regulatory intelligence database to support informed decision-making. 61 Thoroughly research and understand domestic and international laws, regulations, standards, and guidelines related to medical devices to ensure compliance in product registration applications. 61 Lead the development and management of medical device registration strategies and processes aligned with the company's strategic plan, including new product registrations or changes to existing registrations, monitoring and following up on project plans, including document preparation, Animal experiments, type testing,drafting registration documents, submitting applications, and tracking approval progress. 61 Continuously monitor the compliance of marketed products, maintain and update registration certificates to ensure the validity and compliance of all product registrations in cooperation with HQ RA. 61 Communicate project dashboards for pre-market submission projects with key stakeholders and the management team. 61 Ensure compliance of internal company policies/systems/databases/responsibility projects with local regulations. 4. Documentation and Record Keeping: 61 Ensure all regulatory documentation is accurate, complete, and filed in accordance with company policies and regulatory requirements. 61 Maintain an organized and up-to-date database of regulatory submissions and approvals and update HQ about any changes. 5. Quality Management System Maintenance: 61 Improve the quality management system of the company's operations to ensure compliance with medical device operation quality management standards or other national regulatory requirements. 61 Organize relevant parties to participate in irregular reviews and spot checks by regulatory authorities, identify deficiencies in the quality management system, and propose improvement measures. 6. Risk and Crisis Management: 61 Identify, assess, and control risks associated with medical device products, including labeling, storage, and transportation. 61 Monitor the company's external promotional displays and labeling to ensure compliance with regulatory requirements. 61 Establish active communication with Chinese regulatory authorities and identify specific issues or other characteristics of potential regulatory approval risk projects based on changes in national/regional regulations and standards. 61 Lead the response to regulatory crises, including recalls, warning letters, and compliance actions. 7. Cross-Departmental Collaboration and Communication: 61 Collaborate closely with headquarters registration or R&D teams, marketing, sales, operations, and other departments to ensure the smooth realization of product quality and registration requirements. 61 Provide guidance, regulations, agency/industry initiatives, etc., on current/pending matters to internal stakeholders (marketing, manufacturing, R&D, etc.). 61 Serve as the primary interface between the company and external regulatory agencies to coordinate and resolve registration and quality-related issues. 8. Training and Guidance: 61 Conduct training for internal company employees on medical device regulations, quality management systems, and quality awareness. 61 Guide and assist other departments in resolving registration and quality-related issues. 9. Continuous Improvement and Compliance: 61 Monitor industry trends, promptly identify new regulatory requirements or industry best practices, and drive the optimization and upgrading of internal company processes. 61 Lead or participate in the investigation and handling of adverse or quality events, and formulate preventive and corrective measures. 10. Other tasks from Supervisor
Requirements： 61 Bachelor degree in Electrical Engineering or Bio medical Engineering or engineering discipline 61 At least 8 years of experience in Quality Assurance and Regulatory Affairs in the medical device industry 61 Proficient in registration of Class II and Class III active medical devices, surgical instruments and containers, surgical lights, non-active implants, resorbable implants 61 Experience in China local manufactured or local developed products 61 Willing to travelling 61 Proficient in English communication including reading, writing, speaking and listening 61 Strong understanding of NMPA Regulations on medical device administration and other major international regulations 61 Familiar with GMP, ISO 13485 quality management system and international market access requirements such as CE 61 Strong understanding of NMPA medical device management regulations and other major international regulations 61 Be able to manage multiple tasks and perform with accuracy and a high attention to detail 61 Excellent document writing and review skills, with the ability to accurately prepare registration application materials 61 Strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
