Senior Regulatory Affairs Specialist

Job Summary

Senior Regulatory Affairs Specialist is a full-time, remote position responsible for regulatory submissions, compliance activities, and supporting product development in the medical device industry.

Key Responsibilities

• Manage and prepare regulatory submissions for medical devices
• Ensure compliance with applicable regulations and standards
• Collaborate with cross-functional teams to support product development initiatives

Required Qualifications

• Bachelor's degree in a relevant field
• Experience in regulatory affairs within the medical device industry
• Knowledge of FDA and international regulatory requirements
• Ability to work independently and manage multiple projects
• Willingness to travel domestically up to 10% of the time