EXPERIENCE: • Minimum 7-10 years in medical device regulatory compliance experience including 510(k) and PMA submissions. • FDA and Notified Body Audit Experience • Continuous Improvement Training and Demonstrated Leadership • In Depth Knowledge of all applicable Regulatory requirements. • Knowledge of all applicable FDA and OUS regulations (Quality System Regulations (QSR), ISO13485 MDD, et al. • Solid knowledge and experience in matters relating to organizational and personnel management. ... view or apply to job From BioSpace.com - 74 days ago
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