Regulatory Affairs Coordinator - Remote EMEA

RA Coordinator/Admin Support 

1) Prepares, dispatches and files routine Regulatory Affairs documentation 

2) Collaborates with Regulatory Affairs staff to assure adequate prioritization, triage, preparation and dispatch of routine regulatory submissions and/or labeling creation 

3) Finalizes high quality submissions and labeling by editing and formatting documents while adhering to current regulatory guidelines, internal processes and procedures, style and document standards and utilizing company publishing tools, technology, and systems. 

4) Performs operational tasks including publishing, archiving and uploading of documents to document management systems/tools; organizes and maintains components of regulatory submissions and labeling including template preparation, scanning, printing and/or filing. 

5) Collects documents to import, edit and/or create in electronic documentation storage and retrieval systems. 

6) Establishes and organizes electronic structures for local storage of regulatory submissions and/or labeling, including migration and maintenance of regulatory documents. 

9) Compiles, manages, tracks and reports submission related metrics 

10) Coordinates legalization and/or apostille of regulatory documentation for Health Authority submissions as needed 

11) Routes documentation in the Quality Management Systems (e.g. QUMAS, Agile, etc.) as needed 

13) Assists in preparing training materials and conducting training for users of electronic documentation systems and authors of regulatory documents. 

14) Maintains document design consistency for all documents to ensure compliance with company document design standards, including the use and maintenance/creation of templates. 

15) Helps drive process consistency and standards within assigned region. Collaborates with other team members to drive that consistency across all the regions. 

16) Create, manage and/or maintain regulatory strategies in MDRIM for new products, post-market changes, etc. including follow up with each region to ensure responses are provided 

17) Maintain the necessary trackers to ensure strategies and applicable dates are being maintained and kept current, track approval status for each impacted market, etc. 

18) Processing and tracking of product release forms for product approvals including post-approval labeling activities 

19) Other administrative activities to support global RA as needed Position Overview 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.
• Experince with MDRIM

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.
• 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. 

Advance your career with KellyOCG! Apply now with your resume and cover letter via LinkedIn, or contact [insert contact information] for more information.