关于职位
1.Collaborate with stakeholders to understand business needs related to IT systems for medical device quality and regulatory. Conduct in-depth analysis of existing IT systems, processes, and data to identify gaps, inefficiencies, and areas for improvement.
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2.Develop and implement solutions to enhance the efficiency, accuracy, and compliance of medical device companies in areas such as recalls, labeling, and complaints.
3.Work closely with IT developers, vendors, and other stakeholders to design and implement system enhancements, upgrades, and integrations.
4.Provide expertise and guidance on regulatory requirements, industry standards, and best practices for medical device companies in recalls, labeling, and complaints.
5.Support training and change management activities to ensure successful implementation and adoption of new IT solutions.
技能和经验要求
1.Proficient in English writing and communication skills.
2.Bachelor’s degree or higher in Information Technology, Computer Science,Engineering, or a related field.
3.At least 3 years of experience as a Business Analyst, with a focus on IT systems and processes in the medical device industry.
4.In-depth understanding of regulations and requirements for medical device companies in recalls, labeling, and complaints, such as FDA regulations and ISO standards.
5.Experience with IT systems commonly used in the medical device industry, such as ERP systems, inventory management systems, and quality management systems.
6.Proficiency in business analysis tools and techniques, including requirements gathering, process mapping, and data analysis.
7.Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams and stakeholders at all levels.