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Documentation and Labeling Project Specialist

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POST DATE 8/16/2016
END DATE 11/22/2016

Teleflex Reading, PA

Company
Teleflex
Job Classification
Full Time
Company Ref #
4049
AJE Ref #
575894586
Location
Reading, PA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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Opportunity:
Lead projects and activities to improve compliance and efficiency of labeling and PLM processes that govern the creation and maintenance of labeling content and DMR information. Assist the Group Leader, Label Data and Manager Product Data in managing the needs of the department as requested.

Division Information:
Teleflex offers a broad range of central venous access catheters through its proven and trusted ARROW technologies designed to minimize risk and maximize outcomes. Our new VasoNova central venous catheter navigation technology is designed to enable the optimal position for catheter tip location. Visit www.teleflex.com to view our vascular products and learn more about educational opportunities to learn more about vessel health and preservation.

Position Description:
Along with labeling department management, serve as Master Administrator/Change Analyst within the labeling systems Kallik, Bartender, EasyLabel, LabelView.
Provide input to continuously improve the Arrow/Teleflex QS Labeling polices, procedures, work instructions, guidance documents, training, etc.
Follow regulatory requirements, internal procedures and the most recent and best practice guidance avaialble in the areas of Design Control, DMR, labeling, change management, and inspection.
Serve as Subject Matter Expert (SME) in the areas of labeling, labeling change management and the integration of source information from design control.
Develop and implement training materials to be used in the training of personnel in systems within the labeling group.
Support interviewing and training labeling group personnel.
Troubleshoot and work with the appropriate IT departments to implement solutions related to issues with the architecture of the database systems.
Provide input to standardize labeling workflows, change management and PLM practices across the Arrow/ Teleflex documentation/labeling/DMR departments.
Communicate changes/upgrades to the systems cross-functionally as requested by management.
Provide other department support as required by immediate supervisor.
Adhere to and ensure the compliance of Teleflex's Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
Serve as Change Analyst and/or Data Steward within the PLM, ERP and UDI database systems - Agile, SAP, Lansa.
In coordination with engineering teams, prepare new and revised product DMR and MM configurations and documentation using the required PLM, ERP and UDI database systems - Agile, SAP, Lansa.
Create, revise and review DMR-related documents and attachment files submitted for creation or changes. Standardize format, proofread for errors/clarity and verify configuration.
Create, revise and review change management activities for adherence to applicable change management procedures and cross-functional approval levels.
Create or revise product labeling contained within specific software systems (LabelView, Bartender, etc.) as required.
Generate DMR elements and documentation associated with product labeling in coordination with the engineering and labeling team, to ensure adherence to internal labeling procedures, accuracy, completeness and formatting.
Create or revise inspection documentation in the PLM and ERP database systems - Agile, SAP.
Generate and Process electronic DHF and other technical documents in the PLM database. Review documents for formatting, clarity and adherence to GDP.
Serve as Subject Matter Expert (SME) for the areas of change management execution and documentation within the PLM, ERP and UDI database systems.
Lead in training of personnel in systems and act as mentor for personnel as requested.
Train/mentor labeling personnel in formats, processes and systems ie Kallik and Agile.
Train/mentor data management personnel in the use of Agile, SAP and Lansa.
Maintain accurate listings/status reports of all current activities/projects as required by the manager for project tracking and resource loading purposes.
Lead/coordinate documentation or change management activities associated with engineering projects or database maintenance, as directed by project technical teams and/or immediate supervisor.
Provide other department support as required by immediate supervisor.
Act as subject matter expert for Product Brief review and maintenance in Kallik labeling software
Provide guidance for continuous improvement and maintenance for software interfaces: Agile, SAP, Kallik and Lansa.
Working with clinical and R&D support, streamline and consolidate IFU and labeling content as well as product DMR updates to implement.
Act as leader for department when other members are absent.
Act as subject matter expert for non-routine, complex DRM projects, such as supporting acquisitions with the integration of data and systems and complex NPD projects.

Requirements:
BS/BA - technical discipline or equivalent
10+ years experience labeling, documentation, data analysis or database systems
Medical Device Regulatory experience preferred

SPECIALIZED SKILLS & OTHER REQUIREMENTS:
Able to travel domestically or internationally

TRAVEL REQUIRED: 10 %

Company Information:
Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery. We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety.

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.