Regulatory Affairs Coordinator II

In this Regulatory Affairs support role, you will help ensure compliant documentation and processes across the regulatory lifecycle. You'll coordinate change management, manage regulatory systems, and prepare essential registrations and STEDs. You'll serve as a liaison for regulatory data requests and maintain up-to-date SOPs and policies. You'll support cross-functional teams in a fast-paced medical device environment, enabling reliable and compliant product delivery.

• Coordinate Regulatory Change Management process and summarize responses
• Administer regulatory systems and maintain EDMS documentation
• Prepare registrations, STEDs, and regulatory dossiers with Regulatory Affairs Specialists
• Produce regulatory documents (FDA, status reports, presentations)
• Handle external data requests and act as liaison with clients on regulatory matters
• Update SOPs, Work Instructions, and policies to ensure compliance
• Manage departmental administrative tasks (supplies, purchase requisitions, correspondence)

• High School diploma or equivalent in a regulated environment
• 1-3 years Regulatory Affairs or Quality Assurance in medical technology
• Proficient in Microsoft Word, Access, Excel, Outlook

• Strong communication
• Project management
• Multi-tasking
• Knowledge of Medical Device Quality Systems
• Good Documentation Practices
• Notary Public