Sr. Regulatory Affairs Specialist II

📋 Description

• Regulatory guidance to product development and sustaining project teams.
• Authors US FDA premarket submissions (e.g., 510(k), Q-submissions) and international submissions
• Primary regulatory contact for agencies on submissions and negotiate data requirements for timely
• Authors regulatory assessments for proposed changes to products or processes.
• Collaborates on advertising, promotional materials, and product labeling reviews.
• Monitors regulatory landscape changes; writes impact assessments for proposed directives and

🎯 Requirements

• Bachelor’s degree in Engineering, Science, or relevant technical discipline.
• Minimum 7 years in Regulatory Affairs in medically regulated environment; at least 5 years in
• RAC (preferred).

🎁 Benefits

• Treace privacy policy and EEO/Disabled/Veterans employer commitments are described in the