Website CNNC Accuray (Tianjin) Medical Technology Co., Ltd.
CNNC Accuray (Tianjin) Medical Technology Co., Ltd. ("Company") was founded in March 2019 jointly by CIRC, a subsidiary of CNNC, Ltd. and Accuray Incorporated. The Company adheres to the patient-first concept, achieves power alliances, with high starting point, high recognition, high association, high and new platform, highly efficient collaboration and high-end service as the development direction, and is committed to serving tumor patients in China and all other parts of the world and providing patients with effective, safe, personalized and accurate radiotherapy and all-round system solutions and services.
Location: Tianjin, China
Reporting Line: Reports to Director Regulatory Affairs, Quality Assurance and Regulatory Compliance (RQC) for CNNC-Accuray.
- Lead and manage the JV-based site functions related to Regulatory Compliance and Quality System.
- Lead and manage the development and revision of policies and procedures for the Quality Management System which assures Regulatory Compliance of all GMP activities at the Joint Venture Site (CNNC Accuray).
- Provide leadership for the Product Safety Committee as the leadership member for safety reportability (e.g., Adverse Event, Vigilance, Recall) and non-safety field action decisions.
- Act as back-up for the Head of RQC when necessary.
- Lead the management and maintenance of the Quality Management System (certificate of ISO13485 system), including support of the development of meaningful metrics to measure the effectiveness of the quality system.
- Develop, establish, and maintain Regulatory Compliance and Quality System element programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established company, national and provincial, regulatory standards and guidelines, and to ensure lasting customer satisfaction.
- Facilitate the awareness of regulatory and customer requirements throughout the organization.
- Support a culture of continuous improvement that supports the Quality Policy, Quality Manual, and Quality System.
- Determine and establish department(s) goals and objectives in line with business goals and priorities.
- Ensure implementation of approved procedural strategies for earliest possible device approvals and/or clearance.
- Leader for the internal/external and regulatory body inspection plan.
- Point of contact, and host for external Regulatory Agency inspections occurring at any CNNC-Accuray site.
- Preferred or Desired:
- Experience with all appropriate regulations for the CNNC-Accuray (JV) business scope.
- Experience with capital equipment, electro-mechanical or radiation products desirable.
- Experience with (Medical Device) Software Development desirable.
- At least 5years’ experience in Regulatory Compliance, or Quality Assurance/Engineering, including 2 years’ managerial experience.
- Experienced with Quality System Regulations, post-marketing regulations, and Vigilance Reporting.
- Experienced with Medical Device registrations released by NMPA and local authorities.
- Excellent written and verbal communication.
- Minimum bachelor’s degree.
- Be customer focused, drive operational excellence, build trusting relationships, and work with a sense of urgency.
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