Job Description

Summary



Summary:

Reporting to the Project Manager, the Data Analyst will analyze, review, chart, collect and enter global UDI attributes and global labeling information into predefined systems, such as Product Information Management database. This position is responsible for implementing and maintaining central UDI, PIM and related databases which include various product data.

Additional position key elements are to provide detailed analysis, evaluation and recommendations for both UDI and labeling related systems and process improvements, organizational development and maintenance efforts for critical challenges or issues. This position is also accountable for the development and execution of departmental strategies and business processes necessary to meet key, functional and BD Worldwide operational and global product information management standards and regulations (e.g., UDI, PIM).

Responsibilities:

• Assists Project Manager with maintaining master Life Sciences UDI project plan and strategy for compliance with GUDID, EUDAMED and other databases being developed for other countries, e.g., China, S. Korea, Australia, etc.
• Ensures timely and relevant development for strategies driving data attribute collection, management, entry, storage, and global submission.
• Executes activities for collecting, verifying, approving, and maintaining the integrity of data attributes.
• Ensures that all standard data entries and summaries are statistically valid. Assists and educates users in running and interpreting results from relevant databases and reports.
• Provides the definition, scoping, chartering, and reporting efforts for business process analysis and process improvement initiatives.
• Collaborates with multiple stakeholders across the businesses to share project status.
• Participates in cross functional projects for metric assignment and reporting for the improvement of customer experience and satisfaction.
• Responds to internal and external requests for data through the preparation of ad-hoc queries and reports.
• Coordinates priorities with UDI/PIM/eIFU/MDR/IVDR workstreams to ensure the overall success of the relevant programs/projects.
• Suggests tools and processes that provide technical guidance and metrics that enhance program workflows, data entry, and submissions.
• Consults with labeling team and internal clients to define need or problem, supervises, studies and leads surveys to collect and analyze data to provide advice and recommend solutions.
• Responsible for the collection, analysis and regular reporting of labeling activity.
• Maintains, updates and enhances departmental procedures.
• Provides regulatory UDI and labeling guidance to cross-functional teams.
• Participates in industry forums to gain knowledge of new technologies.

Qualifications:

• BS or BA degree in a technical, scientific, data management, or related discipline
• Minimum of 5 years of experience in a related field is required.
• Proficiency in working with master data systems such as SAP, and MS Office suite
• Knowledge of relevant PC software applications and possesses ability to work independently on such programs.
• Must have familiarity working with large data set collection and management.
• Working knowledge of US and international medical device regulations.
• Effective English communication skills, oral and written.
• Demonstrated ability to influence others.

• Demonstrated ability to effectively handle multiple project priorities.
• Excellent organization & prioritization skills.
• Demonstrated problem solving skills.

• Demonstrated ability to lead dynamic work teams across functions and business units.
• Project management/facilitation skills.
• Able to support US-region (east coast) normal working time periods.
• Excellent follow-up and documentation skills.

Primary Work Location MYS Kuala Lumpur - Jalan Kerinchi

Additional Locations

Work Shift

BD