RO Data Management Specialist

Position Summary

The RO Data Management Specialist will execute on regulatory data management activities required to ensure Market Registrations (MRs) and corresponding Ship Control Table (SCT) entries and/or blocks are accurate and complete. This will include a comprehensive review of current production Internal Part Numbers (IPNs) against MRs and other regulatory documentation, with support from technical subject matter experts where required. The RO Data Management Specialist will work closely with counterpart roles, including the RA Data Management Specialists. Together, these roles will be tasked with identifying opportunities to improve predictability and visibility of regulatory data.
The Regulatory Operations data remediation activities referenced above are critical to Teleflex’s operational success, and progress on these activities will be reported regularly to executive leadership.
 

Principal Responsibilities

•    Review and understand IPN variations and their associated market authorization evidence. 
•    Create SCT entries and/or blocks for IPNs within all markets (where a SCT entry and/or block does not already exist). 
•    Review and approve Agile documentation required to process SCT updates. 
•    Review, update, create, and approve MRs in Agile for all product currently approved for global markets.
•    Audit MRs and SCT data for accuracy.  
•    Function as RA Change Analyst to review and process Ship Control Table requests to release appropriate IPNs into certain markets. This includes verifying appropriate documentation required to support these requests. 
•    Support RA Data Management Specialists with additional tasks, as required. 
•    Provide regular and transparent feedback to leadership regarding successes, challenges, and progress. 
•    Partner collaboratively with other functions, including Global Supply Chain, Customer Service, Regional RA, PM RA, and Regulatory Operations. 
•    Execute on other tasks required to effecitvely support regulatory and operational success.
•    Upon successful completion of the SCT and MR remediation activities listed above, the responsibilities of this role will be expanded to take on ownership of additional regulatory data.
•    Adhere to and ensure the compliance of Teleflex's Code of Ethics, all Company policies, rules, procedures, and housekeeping standards.  
 

Education / Experience Requirements

•    Bachelors degree and 3 years of experience managing regulatory data are required. 

Specialized Skills / Other Requirements

•    Excellent attention to detail and organizational skills. 
•    High degree of professionalism and accountability (to success, accuracy, and efficiency). 
•    Excellent oral and written communication skills, with a demonstrated ability to interact effectively with individuals at various levels in the organization.
•    Accurate typing and data entry skills.
•    Cultural awareness and ability to engage with colleagues in different time zones (North America, Europe, Asia).
•    Proficient in Microsoft Office with emphasis on Word, PowerPoint, Excel, and Outlook. 
•    Experience with Agile, SAP, and/or Power BI preferred. 
•    Work effectively under stress.