Senior Regulatory Affairs Specialist

Job Summary

A company in the healthcare industry is looking for a Senior Regulatory Affairs Specialist.

Position Responsibilities:

• Prepare regulatory submissions for FDA and foreign countries
• Develop regulatory strategies and review design transfer activities
• Collaborate with cross-functional teams to ensure regulatory compliance and support product development

Required Qualifications:

• Bachelor's degree in science or related field
• 5 years of regulatory experience in medical devices
• Proven ability to prepare and submit documents to FDA
• Excellent understanding of FDA requirements, ISO Standards, and other international requirements
• Experience working with cross-functional teams on product development and manufacturing projects