Principal Regulatory Affairs Specialist
November 23
Description
• Principle Regulatory Affairs Specialist responsible for regulatory strategy and compliance. • Collaborate with R&D, Marketing, Quality, and other functions throughout product lifecycle. • Lead project management and develop necessary SOPs for regulatory compliance.
Requirements
• 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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