Senior Regulatory Affairs Specialist

Job Summary

Supporting regulatory market access activities, the full-time Senior Regulatory Affairs Specialist will manage regulatory strategies, prepare international submissions, and maintain compliance for medical devices in a hybrid working arrangement near Sarasota, FL; Charlotte, NC; Milford, DE; or York, PA.

Key Responsibilities:

• Assists in the development and execution of regulatory strategies to obtain and maintain regulatory approvals for medical devices
• Prepares and submits international regulatory submissions, including 510(k) submissions and technical files for CE Marking
• Maintains regulatory files and databases to ensure compliance with regulatory requirements

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, MDSAP, EU MDR)
• Proficiency with Microsoft Office Suite and regulatory software