RO Data Management Specialist

Teleflex

Kulim, Kedah
Permanent
Full-time

13 days ago

Expected Travel: NoneRequisition ID: 10208About Teleflex IncorporatedTeleflex 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 SummaryThe 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.

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 employerTeleflex 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.

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