Regulatory Affairs Specialist

Job Summary

A company is looking for a Regulatory Affairs Specialist III.

Key Responsibilities

• Develop regulatory strategies and prepare submissions for product registrations and approvals
• Provide regulatory input throughout the product lifecycle and assess regulatory impacts of changes
• Support audits, inspections, and QMS activities while monitoring regulatory compliance

Required Qualifications

• Bachelor of Science degree
• 5-7 years of regulatory affairs experience in the medical device industry, preferably with respiratory devices
• Experience leading multiple successful 510(k) clearances and CE marking
• Strong understanding of regulatory requirements, including ISO 13485 and FDA regulations
• Proficiency in database systems and advanced Microsoft Excel skills