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

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