Regulatory Affairs Specialist IV

Job Summary

A company is looking for a Regulatory Affairs Specialist IV.

Key Responsibilities

• Develop and implement global regulatory strategies and prepare submissions for product registrations
• Provide regulatory support throughout the product lifecycle and assess impacts of product changes
• Participate in audits and inspections, ensuring compliance with regulatory standards

Required Qualifications

• Bachelor of Science degree
• At least 8 years of regulatory affairs experience in the medical device industry
• Experience leading multiple successful 510(k) clearances and international regulatory registrations
• Strong understanding of ISO 13485, FDA regulations, and EU MDR
• Proficiency in database systems and advanced Microsoft Excel skills