Teleflex · 4 hours ago
Documentation Specialist
Morrisville NC USA
Full-time
Onsite
Entry Level
2+ years expTeleflex is a global provider of medical technologies focused on improving health and quality of life. The Documentation Specialist will review and critique documentation for medical products, ensuring compliance and accuracy in official records.
CommercialHealth CareMedicalMedical Device
Responsibilities
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
Qualification
Required
High School Diploma or equivalent required
2+ years relevant experience. A combination of education and experience will be considered
Intermediate knowledge of Microsoft Suite, specifically Word and Excel
Solid organizational skills and attention to detail
Proven ability to learn and retain working knowledge of new systems and processes
Proven consistent performance with accuracy
Effective communication skills, both verbal and written
Proven team player and customer service oriented
Demonstrated sense of urgency
Solid and consistent ability to work in a fast-paced dynamic environment
Strong adaptation skills to changing priorities
Ability to multi-task and effectively work with competing priorities with solid accuracy
Preferred
Bachelor's degree preferred
Experience in regulated industry highly preferred
Experience with PLM (eg: Agile), ERP (eg: SAP, MDG), VERACITI (Kallik), and/or UDI (eg: Lansa) systems a plus
Company
Teleflex
Teleflex is a manufacturing company that designs and develops medical devices for the healthcare sector.
10001+ employees
H1B Sponsorship
Teleflex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (3)
2022 (2)
2021 (4)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$400M2016-05-12Post Ipo Debt· $400M
1990-01-01IPO
Leadership Team
Liam Kelly
Chairman, President and CEO
Cameron Hicks
Corporate Vice President and Chief Human Resources Officer
Recent News
GlobeNewswire
2026-01-09
2026-01-09
Company data provided by crunchbase