Remote Regulatory Affairs Specialist (FDA/CE) – Contract

Globalchannelmanagement is seeking a Remote Regulatory Affairs contractor with 5-10+ years of global medical device regulatory experience to lead end-to-end FDA 510(k) submissions and EU MDR readiness. You will review design controls, V&V, risk, labeling, and software considerations, and coordinate responses across regulatory authorities and stakeholders.

You will provide leadership for Health Canada submissions and global regulatory strategy, ensuring timely approvals for ophthalmic,