Ra Data Management Specialist

1 week ago


Kulim, Kedah, Malaysia Teleflex Full time

Date:15 Apr 2024

Location:
Kulim, 02, MY

Company:
Teleflex

Expected Travel:
None

Requisition ID: 10207

About Teleflex Incorporated

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 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._


  • Kulim, Kedah, Malaysia Teleflex Full time

    Date:15 Apr 2024Location: Kulim, 02, MYCompany:TeleflexExpected Travel: NoneRequisition ID: 10208About Teleflex IncorporatedGlobal 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...


  • Kulim, Kedah, Malaysia Infineon Technologies Full time

    In your new role you will:R- esponsible for master data setup and changes for work routes to enable lot start, development and improvement activities at customer end. Work route includes process route POR and DEAL route, short route, rework route and flexible trial route. Support project or improvement initiated by customer which require setup and changes of...

  • Quality Specialist

    1 week ago


    Kulim, Kedah, Malaysia Celestica Full time

    Req ID: 118965Remote Position: NoRegion: AsiaCountry: MalaysiaState/Province: KedahCity: KulimGeneral Overview:Functional Area: Quality (QUA)Career Stream: Operations Quality (OPQ)Role: Specialist (SPE)Job Title:Specialist, Operations QualityJob Code: SPE-QUA-OPQJob Level: Band 08Direct/Indirect Indicator: IndirectSummary:Quality Specialist is responsible...


  • Kulim, Kedah, Malaysia United Caps Full time

    Job purposeThe role of the communication specialist is to manage our external and internalcommunications in organization (Malaysia and Europe team) to promote a positive public image and control the dissemination of information on our company's behalf. The communication specialist needs to pitch, write and publish articles and other content through internal...

  • Finance Specialist

    1 week ago


    Kulim, Kedah, Malaysia AT&S Full time

    Be part of our team:AT&S, a world leading high-tech PCB & IC substrates company, industrialises leading-edge technologies for automotive, aerospace, industrial, medical, consumer electronics and communication networks. We are looking for talent eager to shape the future of our interconnected world. With our headquarters in Austria, plants in Austria, China,...


  • Kulim, Kedah, Malaysia AT&S Full time

    Be part of our team:Operation Specialist (Production Operator)**:Your Responsibilities: Follow the EHS requirement. Complete the production tasks according to the requirements. Abide SOPand Operation instructions,and assist the maintenance department Safekeeping the material, including the chemical, raw material,consumables and the semimanufactured. Strictly...


  • Kulim, Kedah, Malaysia Celestica Full time

    Req ID: 119115Remote Position: HybridRegion: AsiaCountry: MalaysiaState/Province: KedahCity: KulimGeneral Overview:Functional Area: Supply Chain Management (SCM)Career Stream: Supply Chain Management (SCM)Role: Analyst (ANA)Job Title: Analyst, Product DataJob Code: ANA-SCM-PRDJob Level: Level 07Direct/Indirect Indicator: IndirectSummary:Must be competent in...


  • Kulim, Kedah, Malaysia Celestica Full time

    Req ID: 119033Remote Position: NoRegion: AsiaCountry: MalaysiaState/Province: KedahCity: KulimGeneral Overview:Functional Area: Supply Chain Management (SCM)Career Stream: Supply Chain Management (SCM)Role: Associate (AST)Job Title: Associate, Product DataJob Code: ASS-SCM-PRDJob Level: Level 06Direct/Indirect Indicator: IndirectSummary:We are known as...


  • Kulim, Kedah, Malaysia AT&S Full time

    Be part of our team:Learning & Development Advisor/ Specialist:Your Responsibilities: Develops and implements appropriate training strategies, courseware and job aids to support and streamline the learning process Collaborate with key stakeholders to understand specific organizational, departmental, individual and/or external regulatory requirements on...

  • IT SAP Specialist

    1 week ago


    Kulim, Kedah, Malaysia Celestica GBS Malaysia Sdn Bhd Full time

    Job Responsibilities: Provide SAP functional support on SAP logistic modules; and provide leadership and coaching to new or junior resources in the team. Work closely with users to understand requirements and develop solutions in accordance with organization/ client standards and architecture. Analyze business requirements and mapping of those to SAP best...

  • Data Analyst Intern

    1 week ago


    Kulim, Kedah, Malaysia J&T Cargo (Malaysia) Sdn Bhd Full time

    Job description- _Data Entry:_Accurately record stock counts and adjustments in the inventory management system.- _Quality Control:_ Ensure that all stock items are in good condition and properly labelled during the stocktaking process.- _Communication:_ Collaborate with cross-functional teams, such as Purchasing, Warehousing, and Finance, to resolve...


  • Kulim, Kedah, Malaysia Agensi Pekerjaan Graceful (M) Sdn Bhd Full time

    Major Job role:1] Cost optimization and supplier management for existing mass production projects2] Materials shortage support for all mass-run projects3]Develop and manage MRO/Service supplier resources to optimize MRO/Service costResponsibilities and Authority:Be responsible for the continuous price reduction and annual price negotiation of the mass...


  • Kulim, Kedah, Malaysia Infineon Technologies Full time

    In your new role you will: R- esponsible for the management, operations and deployment of security manpower, resources and activities to fulfil IFKM's security needs and function. L- ead the efficient and effective functioning of the security operation steam, electronic security systems and security equipment at IFKM at all times. E- nsure security...

  • IT Advisor

    1 week ago


    Kulim, Kedah, Malaysia Celestica Full time

    Req ID: 120231Remote Position: NoRegion: AsiaCountry: MalaysiaState/Province: KedahCity: KulimGeneral Overview:Functional Area: Information Technology (ITM)Career Stream: IT Solutions (SOLN)Role: Senior Specialist (SSP)Job Title: Senior Specialist, IT SolutionsJob Code: SSP-ITM-SOLNJob Level: Band 9Direct/Indirect Indicator: IndirectSummary:The Senior...


  • Kulim, Kedah, Malaysia Celestica Malaysia Sdn Bhd Full time

    Job Description :Provide SAP functional support on SAP logistic modules; and provide leadership and coaching to new or junior resources in the team. Work closely with users to understand requirements and work with level 2 / level 3 to develop solutions in accordance with organization/ client standards and architecture. Analyze business requirements and...

  • Sales Manager

    1 week ago


    Kulim, Kedah, Malaysia XSD INTERNATIONAL PAPER SDN BHD Full time

    Market research, data collection and market info integration.Market demand, customer organization, product positioning, analysis customer requirements and competitor info.Data collection and data analysis of product dynamics, procedure for business plan, understand market trends, collection market & customer detail information and research compilation.Lead...


  • Kulim, Kedah, Malaysia DURAMITT SDN BHD Full time

    Responsibilities:1.Recruitment: Manage recruitment processes, continually expand recruitment channels, and establish a talent pool. Handle onboarding procedures, establish and maintain employee files, and ensure timely updates and improvements. Monthly verification of labor contracts to ensure timely renewals and mitigate labor risks.2.Employee Records and...


  • Kulim, Kedah, Malaysia INTEL Full time

    Management and oversight of all cross border operations in Malaysia manufacturing activity,FKM7, including site related activities and ensuring trade compliance related to duty optimization programs. Ensure valuation, classification, origin, Trade mode, Malaysia related and all Customs requirements are fully satisfied to expedite cross border movements and...


  • Kulim, Kedah, Malaysia Infineon Technologies Full time

    In your new role you will:P- erform cost savings verification and business case justification S- ite responsible for standard cost toolbox including yearly updates, content assessments and controlling. R- esponsible for new projects implementation & financial statement assessment and internal control P- roject budgetary control, funding and insurance...


  • Kulim, Kedah, Malaysia Agensi Pekerjaan Pasona Sdn. Bhd. Full time

    About the CompanyWell-established MNC Japanese company which manufacturing electronic components.Roles & Responsibilities The main focus is on data management of systems. To manage the data in system (SAP and Quick Base), combines each data and compare with the actual stocks. In the event of any discrepancy found, analyze the cause and implement an...