Job Description

Regulatory Affairs Specialist II at Penumbra prepares and maintains regulatory submission documentation for medical devices across global markets. The role involves coordinating approvals for clinical research and commercial distribution while ensuring compliance with international regulatory standards.

Responsibilities

• Prepare submissions for IDE, 510(k), CE-Mark, UKCA, and other regional regulatory approvals
• Track multiple concurrent projects and maintain existing approvals and documentation
• Communicate with regulatory agencies and in-country personnel to facilitate global clearances
• Review design control documents and quality system procedures for regulatory compliance
• Monitor competitor FDA clearances and research regulatory requirements for strategic planning

Requirements

• Bachelor's degree in science or related field with 2+ years experience
• Regulatory medical device experience preferred
• Strong written and oral communication skills
• Proficiency with MS Word, Excel, and PowerPoint
• Excellent organizational and multi-project prioritization abilities
• High attention to detail and accuracy

Compensation: $90,000 - $125,000 base per year

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