Senior Regulatory Specialist

Job Summary

A company is looking for a Senior Regulatory Specialist to fulfill regulatory requirements for global approvals and compliance.

Key Responsibilities

• Prepare and maintain pre-market and post-market submissions with minimal oversight
• Provide project-level regulatory strategy and support for new product development and lifecycle projects
• Assess and approve post-market changes, product/process nonconformances, and execute CAPA for regulatory processes

Required Qualifications

• Bachelor's Degree from an accredited institution required
• Minimum 5 years of experience in FDA/ISO medical devices quality management system standards required
• 5 years of experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations required
• Technical writing skills required