Regulatory Affairs Coordinator
hace 6 días
KellyOCG is seeking a detail‑oriented and highly organized Regulatory Affairs (RA) Coordinator / Administrative Support to join our client’s dynamic Regulatory Affairs team, working remotely as a full‑time team member. This role supports the preparation, management, and dispatch of regulatory documentation, ensuring compliance with regulatory requirements and internal standards across global RA operations. Key Responsibilities Prepare, dispatch, and file routine Regulatory Affairs documentation, ensuring accurate submissions. Collaborate with Regulatory Affairs staff to prioritize, triage, and manage regulatory submissions and labeling creation. Edit, format, and finalize high‑quality submissions and labeling in line with regulatory guidelines and company standards, using publishing tools and technologies. Publish, archive, and upload documents; organize and maintain templates, scanned files, and submission archives. Collect, import, edit, and create documents in electronic storage/retrieval systems; establish and maintain electronic structures for documentation. Compile, manage, track, and report submission‑related metrics. Coordinate legalization/apostille of regulatory documents for Health Authority submissions. Route documentation in Quality Management Systems (e.g., QUMAS, Agile). Assist in preparing and delivering training materials to users and authors of regulatory documents. Ensure document design consistency and support template creation to maintain company standards. Promote process consistency and standardization across regions; collaborate globally for harmonization. Create and maintain regulatory strategies in MDRIM for new products and post‑market changes; track strategies and approval status for each region/market. Track and process product release forms for product approvals, including post‑approval labeling activities. Provide additional administrative support to global RA teams as needed. Utilize the ARIBA purchasing tool for relevant tasks. Qualifications & Skills Previous experience in Regulatory Affairs support, administration, document management, or a related field preferred. Experience with document management systems (e.g., QUMAS, Agile) and publishing tools. Experince with Medical Device Regulation Information Management. Strong organizational skills and attention to detail. Excellent written and verbal communication abilities. Ability to work collaboratively within a multifunctional, remote team. Experience with ARIBA purchasing tool is a plus. Proficient with Microsoft Office Suite (Word, Excel, PowerPoint) and other business software. Ready to take the next step in your career with KellyOCG? Submit your application through LinkedIn or reach out to KellyOCG for additional information about this opportunity. #J-18808-Ljbffr
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WorkFromHome, Colombia Kelly Science, Engineering, Technology & Telecom A tiempo completoA leading regulatory affairs firm is seeking a detail-oriented Regulatory Affairs (RA) Coordinator / Administrative Support to join their team remotely. This role involves preparing and managing regulatory documentation, ensuring compliance with standards, and collaborating with global teams. Candidates should have experience in Regulatory Affairs support,...
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