Quality Assurance and Regulatory Affairs Manager

With the primary focus on quality assurance and regulatory affairs, the QA/RA Mgr will also provide support in specific administrative tasks and support our key account with technical, quality assurance and regulatory documentation.The QA/RA Mgr will provide support in handling emails and all communication between customers, tasks and help to provide accurate quality control and regulatory documentation to key accounts.A great level of detail and a technical background is required. Good control of the English is required and other languages are a plus. This position will work closely with the Key Account Manager, Customer Service Manager, and global QA/RA team at the corporate office in Japan.PurposeWith the primary focus on quality assurance and regulatory affairs, the QA/RA Mgr will also provide support in specific administrative tasks and support our key account with technical, quality assurance and regulatory documentation. The QA/RA Mgr will provide support in handling emails and all communication between customers, tasks and help to provide accurate quality control and regulatory documentation to key accounts. A great level of detail and a technical background is required. Good control of the English is required and other languages are a plus. This position will work closely with the Key Account Manager, Customer Service Manager, and global QA/RA team at the corporate office in Japan.ActivitiesGain and maintain a good understanding of all quality assurance and regulatory documentation through close cooperation with the corporate quality assurance and regulatory team in Japan.Monitor external changes to the regulatory environment to ensure the continued compliance to the regulatory system.Support customers with regulatory related documents when needed.Review and keep up-to-date all technical customer documentation and contracts.Manage product complaints following our ISO-9001 quality management procedures and identify opportunities to improve product quality.SpecificationsKnowledge, Skills and Abilities (i.e. minimum education, years of experience, etc.)Quality Assurance and/or Regulatory Affairs responsibilities required.Technical experience is a plus.Minimum of 5 years' experience in related responsibilities.Fluent in English and conversation level French and German is a plus.Working knowledge of Microsoft WORD, EXCEL and POWERPOINT and the willingness to learn new software. Knowledge in EXACT or other accounting systems a plus.Excellent organizational, interpersonal and analytical skills.Ability to develop close, effective working relationship with customers through email and telephone.Core Competencies:People Skills - listening, interpersonal, savvy, cooperation and conflict resolution, oral and written communication.Customer Focus Skills - customer service, quality orientation, communicates clearly, concisely, effective and persuasively in writing.Personal Skills - dependability, versatility/flexibility, creativity, action oriented, personal learning, functional and technical knowledge, integrity and trust. Is action oriented and full of energy for the things he/she sees as challenging?DisclaimerThis job description is not intended, and should not be construed, to be an all-inclusive list of all responsibilities, skills, effort, or working conditions as associated with a job. While this description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove from particular jobs and to assign other duties necessary.

#J-18808-Ljbffr Compliance & Regulatory Affairs