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Regulatory Technical Spec 4

Division: Siemens Healthineers Business Unit: Laboratory Diagnostics Requisition Number: 217373 Primary Location: United States-Massachusetts-East Walpole Assignment Category: Full-time regular Experience Level: Senior level Education Required Level: Bachelor's Degree Travel Required: 20% Division Description: Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services. With 45,000 employees Siemens Healthineers is one of the worlds largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers needs. So that more people can have a life that is longer, richer, and more filled with happiness. For more information, please visit:? http://www.usa.siemens.com/healthineers Job Description: Project DRACO: This project is responsible for executing a Manufacturing Site transfer from the Walpole Facility to Shanghai China for the Siemens Healthineers ADVIA Centaur and clinical chemistry product lines Specific ? Responsibilities: Provides regulatory support for the China manufacturing Transfer project (Project DRACO) in Walpole Ma. by ?developing regulatory strategies for the immediate transfer and for future product distribution channels and will assess the regulatory impact of the manufacturing transfer strategy. Assesses regulatory impact of design and manufacturing process changes, reviews verification and validation plan designs, works with Import/export logistics to facilitate Raw material transfer strategies, participates in Risk assessments, supports DHF file remediation and, as needed, assists with the preparation and submission of ?CFDA? registration dossiers. ? Act as liaison with CFDA, China, Tarrytown, Walpole? RA teams ?and project DRACO core team. Interacts with China based RA team, and US RA team as needed. Maintains awareness of global regulatory legislation and assesses impact of changes to the business. May support audits and inspections by CFDA. ? Requirements: Strong leadership, interpersonal, communication and organizational skills required. Must possess a high level of critical and strategic thinking skills and be a detail oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities. Must be able to set priorities as well as adapt to changing priorities. Experience with U.S. FDA 510k and/or PMA submissions, CFDA submissions and interaction with reviewers required. Knowledge and experience with global registrations and development of in vitro diagnostic medical devices a plus. ? ? General Job Family Responsibilities: Requirements: Assists the China RA team in writing and filing of appropriate CFDA ?submission dossiers to ensure devices are commercially available according to the Project DRACO Master schedule. Guides the review of promotional material and device labeling for regulatory compliance. Guides regulatory projects, project schedules, and product introduction process. Guides the decision making process on regulatory submission issues using historical knowledge, legal counsel and CFDA's current regulations on medical device industry. ? Education: ? BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas. ? Knowledge and Experience: ? Demonstrates and applies comprehensive knowledge of field of specialization to the successful completion of complex assignments. Demonstrates advanced knowledge of concepts, practices, and procedures of particular area of specialization. Demonstrates significant knowledge of organization's business practices and issues faced and contributes to problem resolution of those issues. Typically 8-10 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable. ? Travel: ? Some Travel to Shanghai, Beijing and Tarrytown maybe required.? 20% - provided by Dice
Consulting, Development, Diagnostic, FDA, HTTP, Labeling, Laboratory, Management, Medical Device, Powerhouse, Project, Validation


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