Serves as the Regulatory representative providing regulatory guidance to product development and
Authors US FDA premarket submission (e.g., 510(k), Q-submissions) and international submissions for
Serves as primary contact for regulatory agencies on assigned submissions and negotiates submission
Authors regulatory assessments for proposed changes to products or processes.
Collaborates with Marketing, Sales, Legal and Regulatory partners for timely review of advertising
Monitors regulatory landscape changes and authors impact assessments to key proposed or issued

🎯 Requirements

Bachelor’s degree in Engineering, Science, or relevant technical discipline is required.
Minimum of nine (9) years of Regulatory Affairs related experience in a medically regulated
Regulatory Affairs Certification US (RAC) through Regulatory Affairs Professional Society (RAPS) is

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