Regulatory Affairs Manager

Regulatory Affairs Manager (Medical devices) We are seeking a highly skilled professional with a medical background to coordinate and manage multi-center clinical trials, ensuring compliance with ICH-GCP and Hong Kong/Mainland regulations. This role requires regular travel between Hong Kong and Mainland China to oversee trial execution and stakeholder collaboration. Responsibilities Regulatory Strategy & Submissions Lead NMPA registration processes for medical devices, including product classification, technical documentation preparation (e.g., risk assessment, clinical evaluation reports), and coordination with testing laboratories. Manage overseas regulatory registrations (FDA, CE, UKCA), ensuring compliance with regional requirements (e.g., FDA 510(k)/PMA, EU MDR/IVDR, UKCA technical files). Collaborate with R&D, QA/QC, and manufacturing teams to align product development with regulatory standards. Quality & Compliance Oversight Ensure adherence to ISO 13485 and GMP standards across product lifecycle, including design controls, production processes, and post-market surveillance. Conduct internal audits and support external audits by regulatory bodies (e.g., NMPA, FDA, Notified Bodies). Regulatory Intelligence & Training Monitor updates in global regulations (NMPA, FDA, EU, UK) and communicate impacts to internal stakeholders. Develop training programs for cross-functional teams on regulatory requirements and compliance. Cross-functional Collaboration Liaise with external partners, including CROs, testing agencies, and regulatory consultants, to expedite approvals. Support international market expansion by addressing regional regulatory barriers. Qualifications Education: Bachelor’s degree or higher in Life Sciences, Biomedical Engineering, or related fields. Advanced degrees (e.g., MSc, PhD) preferred. Experience: 5+ years in medical device regulatory affairs with proven success in NMPA registrations and at least 2 FDA/CE/UK approvals; in-depth knowledge of ISO 13485, GMP, and quality system standards. Skills: Proficiency in technical documentation (e.g., design dossiers, clinical evaluation plans); strong project management and communication skills for global regulatory coordination. Language: Fluency in English and Mandarin (written and spoken). Preferred Qualifications: Experience with software-as-a-medical-device (SaMD) or AI-driven medical technologies; certification in regulatory affairs (e.g., RAC, CE Marking expertise). #J-18808-Ljbffr