Documentation Specialist

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As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and u that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, Quik Clot™, Rro Lift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit .

Surgical – Whatever the latest surgical breakthrough looks like, Teleflex is working to make it happen. From our Mini Lap™ Percutaneous Surgical System to our Weck™ Hem-o-lok™ Polymer Locking Ligation System
, and Weck™ EFx Shield™ Fascial Closure System
, our portfolio of products adds up to a powerful offering of solutions that help to improve patient outcomes. These innovative, minimally invasive surgery products are offered alongside time-tested and trusted Pilling™ Surgical Instrument and Lightsource solutions, as well as the Titan SGS™ Stapler portfolio that equips surgeons with advanced bariatric technologies that are designed to deliver a consistent sleeve shape to help enhance perioperative outcomes in sleeve gastrectomy.

This wide array of devices and instruments helps meet the challenges of an evolving healthcare environment.

Review and critique documentation for new, revised, custom, and foreign products for complete official documentation records required to manufacture medical products.

• Serve as Change Analyst and/or Artwork Data Manager and/or Data Steward within the PLM, VERACITI, ERP/MDG, and UDI database systems – Agile, SAP/MDG, DSD (Lansa), and VERACITI (Kallik).
• In coordination with the Engineering team, prepare new and revised product DMR and MM configurations and documentation using the required PLM, ERP/MDG, and UDI database systems – Agile, SAP/MDG, DSD.
• Manage Pilot/Prototype ECOs, Production ECOs/ECRs, Sustaining Change ECOs/ECRs, MCOs, ADCs, DMR review, SAP/Pre-Checks (MM Forms/Lansa Input Forms), SAP review, IPN and GTIN management, DSD registrations/publications.
• Review DMR-related documents and attachment files submitted for creation or changes. Standardize format, proofread for errors/clarity, and verify configuration.
• Submit documents for approval signatures, coordinate corrections and changes by approvers, and issue documentation package(s). Update appropriate personnel on open projects as required.
• Assist and communicate with Engineering, Marketing, and Regulatory in the preparation of new or revised product documentation packages. Assist in formalizing documentation, as required.
• Generate product labeling in VERACITI. Perform proofreading of product labeling in coordination with the labeling team, to ensure adherence to internal labeling procedures, accuracy, completeness, and formatting.
• Import and maintain current, accurate files for figures, graphics, and scanned images required for product labeling.
• Follow regulatory requirements, internal procedures, and the most recent and best practice guidance available in the areas of Design Control, DMR, change management, and inspection.
• Process electronic DHF documents in the PLM database. Review documents for formatting, clarity, and adherence to GDP.
• Provide other department support as required by manager.
• Adhere to and ensure the compliance of Teleflex' Code of Ethics, all Company policies, rules, procedures, and housekeeping standards.

• High School Diploma or equivalent required. Bachelor’s degree preferred.
• 2+ years relevant experience. A combination of education and experience will be considered.
• Experience in regulated industry highly preferred.
• Experience with PLM (eg: Agile), ERP (eg: SAP, MDG), VERACITI (Kallk), and/or UDI (eg: Lansa) systems a plus.