Full-Time Senior Specialist/Manager, Regulatory Affairs
Job Description
The Senior Specialist/Manager, Regulatory Affairs drives the execution of regulatory initiatives for multiple Software as a Medical Device (SaMD) products at various stages in lifecycle management. This role will support the preparation, review and submission of documents to the FDA and other global regulatory authorities leading up to marketing authorization. The Senior Specialist/Manager collaborates with stakeholders from medical, commercial, quality, product, and program teams to assure that our products are presented to regulatory authorities according to all applicable regulations for SaMD in alignment with the company’s strategic goals. In advance of meetings with the FDA and other regulators, the Senior Specialist/Manager prepares cross-functional team members to enable productive interactions with the Agency and attends the meetings as a representative of the Click Therapeutics regulatory team.
This position is based out of Click’s headquarters located in Tribeca, NYC, at the center of one of the fastest-growing digital health communities or at one of our industrious offices in Boston, MA. We have a hybrid working model that consists of at least 3 days in office each week.
How to Apply
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