Job Description

1.Bachelor’s degree or above, majoring in Biomedical Engineering, Medical Devices, Pharmacy, Chemistry, Mechanical Engineering, Electronic Engineering, Clinical Laboratory or other science & engineering disciplines. Minimum 3 years of full-time experience in international medical device registration with proven overseas B2B project experience (experience in liaising with overseas Notified Bodies, foreign clients or global registration agents is required). 2.Proficient in EU MDR and IVDR; familiar with FDA 510(k), ISO 13485, ISO 14971, ISO 10993, IEC 60601 and other core international standards. Have independently led the full-cycle international registration of Class II/Class III active medical devices or IVD products with successful certification records, covering project initiation, testing, document compilation, deficiency response and certification issuance. 3.Fluent oral English for daily work, capable of participating in English technical meetings, overseas on-site audit defense, drafting English registration documents and conducting cross-border business & technical communication. CET-6 or above with proficient medical English reading & writing skills. 4.Capable of managing multiple parallel projects and coordinating cross-functional stakeholders; able to build registration workflows, risk registers and milestone tracking systems independently. Meticulous, resilient, result-oriented and able to work under pressure. Preferred Qualifications

1. Experienced in both active medical device and IVD international registration, with successful registration cases in Brazil ANVISA, Southeast Asia, Japan, South Korea and other regional markets.
2. Hold ISO 13485 Internal Auditor or other medical device registration training certificates; familiar with design control via DHF/DMR, MDD to MDR migration batch certification and medical device cybersecurity compliance.
3. Previous working experience in leading domestic medical device manufacturers or export-oriented ODM/OEM enterprises; experience in building registration systems from scratch and managing registration teams.
4. Hold valid US or Schengen visas for short-term overseas business trips to attend on-site audits and client technical exchanges. 1.Global Registration Project Management

Take charge of the full-lifecycle international registration of our active medical devices, phototherapy equipment and IVD products for NMPA (China), EU MDR/IVDR, US FDA 510(k), Brazil, Southeast Asia, Japan, South Korea, Australia and other regions. Formulate annual overall registration plans and product-specific registration strategies. Manage multiple parallel product lines, control project schedule, cost and risk, and complete registration application, supplementary response, on-site audit, certification acquisition, certificate change, renewal and post-market compliance maintenance on schedule. 2.Compliance Control & Review of Registration Documents Lead the drafting, internal audit and standardized management of full sets of technical registration documents, including product technical requirements, ISO 14971 risk management reports, ISO 10993 biological evaluation reports, clinical evaluation reports, instructions for use & labeling, DHF/DMR design history files, etc. Liaise with testing laboratories, EU Notified Bodies, national drug regulatory authorities and overseas local registration agents. Be responsible for drafting English registration documents, replying to official deficiency letters and technical inquiries to eliminate risks of registration rejection in advance. 3.Regulatory System Establishment & Internal Compliance Empowerment Track updates of global medical device regulations such as MDR, IVDR and FDA local regulatory rules, conduct regulatory interpretation and gap analysis. Establish internal SOPs for registration, document review specifications and regulatory training systems. Provide pre-project compliance review, regulatory guidance during design & development for R&D, Quality, Production and overseas Sales teams, and support system audits, third-party factory inspections and overseas official on-site audits. 4.Team Management & Internal & External Coordination Manage the registration team including work allocation, task assignment, new staff mentoring, performance appraisal and project review. Maintain cooperative relationships with testing institutions, Notified Bodies and overseas local registration agents, and select cost-effective third-party partners. Cross-functionally align R&D, Quality, Marketing and Supply Chain teams to meet overseas clients’ market access requirements and provide full compliance support for global business expansion.

Job Tags

Full time, Temporary work, Work experience placement, Local area, Overseas

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