Senior Regulatory Affairs Specialist

Job Summary

A company is looking for a Senior Regulatory Affairs professional to lead global medical device submissions and regulatory strategy.

Key Responsibilities:

• Lead and author regulatory submissions for U.S. and international markets
• Own regulatory strategy and execution for new product development programs
• Serve as the regulatory representative on cross-functional product development teams

Required Qualifications:

• Bachelor's degree in Engineering, Science, Regulatory Affairs, or a related technical field
• Typically 5-15+ years of experience in medical device regulatory affairs
• Demonstrated ownership of FDA submissions and EU technical documentation
• Extensive experience with post-market surveillance and regulatory maintenance activities
• Working knowledge of international regulatory frameworks and standards