Project Management Associate

We are seeking a detail‑oriented Project Coordinator to support the review, processing, and coordination of electronic Instructions for Use (IFU) documentation. This role focuses on reviewing submitted IFUs for accuracy and completeness, coordinating with cross‑functional teams, and managing documentation workflows within enterprise content management systems. The position does not involve technical writing, but rather review, validation, and system processing to support regulatory approval and publication.

• Review electronic IFUs submitted by writing and localization teams for accuracy, completeness, and consistency
• Process IFU documentation through enterprise systems used for content management and distribution
• Review submission requests and identify issues related to forms, documentation, or data alignment
• Coordinate with Regulatory Affairs, Engineering, Manufacturing, and other cross‑functional teams to clarify questions and ensure alignment prior to approval
• Verify document information such as titles, production numbers, dates, model numbers, and PDFs for accuracy and consistency with business requirements
• Identify IFUs requiring updates or removal and escalate discrepancies as needed
• Route completed documentation to Regulatory Affairs for final review and approval
• Support publication of approved IFUs to external platforms and websites
• Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP)
• Prioritize work effectively and identify urgent reviews to meet business timelines
• Communicate clearly with stakeholders beyond the immediate project team

• Bachelor’s degree with 2–5 years of relevant experience, or equivalent combination of education and work experience
• Strong data entry and document review experience
• Knowledge of Good Documentation Practices (GDP)
• Excellent attention to detail and organizational skills
• Strong written and verbal communication skills
• Ability to manage multiple priorities and meet deadlines
• Comfortable working cross‑functionally with regulatory, engineering, quality, and operations teams

• Experience with IFU, labeling, regulatory, quality, or technical documentation review
• Familiarity with enterprise content management systems (e.g., Informatics, AEM, or similar platforms)
• Background in regulatory affairs, quality assurance, documentation, editing, or proofreading
• Experience working in regulated industries