Location: Remote

Overview:

Regulatory Affairs Specialist will provide regulatory oversight and subject matter expertise for design controls remediation activities, including review and support of regulatory and design documentation.

Required Experience:

• Experience in Regulatory Affairs within the medical device industry
• Experience supporting regulatory aspects of remediation initiatives
• Familiarity with global regulatory requirements and submission documentation
• Experience with labeling, product claims, and design documentation review

Key Responsibilities:

• Provide regulatory oversight during remediation activities
• Review design documentation including User Needs, Design Inputs/Outputs, Verification & Validation, and Design Transfer
• Evaluate regulatory impact of remediation activities
• Support updates to regulatory documentation
• Provide expertise on labeling and product claims
• Document regulatory review outcomes and recommendations