Regulatory Affairs Specialist

Job Summary

A company is looking for a Regulatory Affairs Specialist II.

Key Responsibilities

• Leads regulatory submissions to obtain and maintain approvals for medical devices
• Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle
• Reviews and interprets regulatory requirements to ensure compliance

Required Qualifications

• Bachelor's degree in a relevant field such as life sciences or regulatory affairs
• 5+ years of experience in regulatory affairs, preferably in the medical device industry
• Experience with leading regulatory submissions, including 510(k) and CE marking
• In-depth knowledge of FDA regulations and international standards (e.g., ISO 13485)