RA Data Management Specialist

Expected Travel: None

Requisition ID: 10207

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Global Operations – Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

The RA Data Management Specialist will execute on regulatory data management activities required to ensure global Market Registrations (MRs) and corresponding Ship Control Table (SCT) entries and/or blocks are accurate and complete for all markets (including US/CA/EU-CE). This will include a comprehensive review of current Internal Part Numbers (IPNs) against MRs, licenses, amendments, 510(k)s, PMAs, letters to file, and/or Regulatory Impact Assessments, with support from technical subject matter experts where required. The RA Data Management Specialist will work closely with counterpart roles, including other RA Data Management Specialist(s) and RO Data Management Specialist(s). Together, these roles will be tasked with identifying opportunities to improve predictability and visibility of regulatory data.
The global 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 the difference in various IPNs to understand which IPN ties to which MR, license, amendment, 510(k), PMA, letters to file, and/or Regulatory Impact Assessment.
•    Create SCT entries and/or blocks for all IPNs and for all global markets (where a SCT entry and/or block does not already exist), including US/CA.
•    Review and approve Agile documentation required to process SCT updates. 
•    Review, update, create, and approve MRs in Agile for all product currently approved per market.
•    Audit MRs and SCT data for accuracy.  
•    Support other RA Data Management Specialist(s) and RO Data Remediation Specialist(s) 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.
 

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time. 

Teleflex is an equal opportunities employer

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.