Senior Regulatory Affairs Specialist
August 27
🏢 In-office - Brooklyn
Description
• Responsible for planning and executing regulatory submissions and ensuring regulatory compliance. • Provide regulatory strategy and guidance on medical device throughout the product development lifecycle, including clinical validation, analysis for stand-alone and clinical performance; AI/ML-enabled devices and SaMD products. • Review and approve R&D, quality and clinical documentation for submission. • Partner with cross-functional teams to define scope and innovative regulatory strategy for design and development activities. • Assist with product labeling and review for compliance. • Keep abreast with FDA and international guidance documents and regulations. • Contribute to developing policies, processes, and SOPs necessary to support regulatory compliance including identification of opportunities for improved efficiencies within processes. • Actively participate in problem-solving discussions and recommend solutions. • Partner with the cross-functional team to allow for streamlined workflows, timely and relevant submissions, and thoughtful and creative approaches for the BCI space. • Experience with device software development. • Ability to manage multiple projects and work in a fast-paced, changing environment.
Requirements
• 4-6 years of experience in U.S. and global Class II or III medical device regulatory affairs (active implantable device is a plus) • Submissions experience in medical devices, SaMDs, AI/ML-enabled medical devices, deep learning-enabled devices, and digital health software. • Have experience in developing complex submissions. Strong organization and attention to detail. • Work independently and cross-functionally with minimal supervision.
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