Job Description

Regulatory Affairs Specialist I at Penumbra will coordinate and prepare regulatory submission documentation for medical device approvals across global markets. The role involves supporting worldwide regulatory submissions, maintaining compliance documentation, and collaborating with regional teams to facilitate product clearances.

Responsibilities

• Prepare regulatory submissions including 510(k), CE Mark, UKCA Mark, IDE, and other regional approvals
• Track and manage multiple concurrent regulatory projects and submissions
• Maintain submission and approval documentation according to internal procedures
• Research regulatory intelligence including competitor products and regulatory updates
• Support labeling reviews and regulatory change assessments for product modifications

Requirements

• Bachelor's degree in relevant discipline or equivalent education/experience
• Regulatory medical device experience preferred
• Proficiency in Word, Excel, PowerPoint and standard office software
• Strong written, oral, and interpersonal communication skills
• Ability to apply technical standards and regulatory principles
• Knowledge of ISO 13485 and regional regulatory requirements

Compensation: $77,000 - $98,000 base annual salary

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