Senior Regulatory Affairs Specialist

Job Summary

A company is looking for a Senior Regulatory Affairs Specialist (Remote/Flexible).

Key Responsibilities

• Support regulatory approval processes for medical devices in domestic and international markets
• Assist with pre-market and post-market filings and manage submission deliverables
• Review and approve project documentation and evaluate change assessments for compliance

Required Qualifications

• B.S. / B.A. degree or a minimum of 7 years of regulatory/quality experience in the medical device industry
• Minimum 5 years of regulatory/quality experience in the medical device industry
• Knowledge of regulatory guidelines and requirements (domestic and international)
• Experience with reviewing Engineering Change Orders (ECOs) and regulatory documentation
• Understanding of relevant regulations such as 21 CFR 820, ISO 13485, and MDD/MDR