Sr. RA Specialist

2 weeks ago

Indiana, United States Intuitive Full time

Job Description Primary Function of PositionThe Senior Regulatory Affairs Specialist serves as the primary regulatory lead on projects involving complex electromechanical, software controlled robotic systems, instruments and accessories, SaMD and advanced imaging systems. The Sr. RA Specialist works across the organization and liaises with global regulatory counterparts on a wide range of products including capital equipment, instruments and accessories (single use or re-usable), and software, focusing on supporting ongoing changes and continuous improvement to these products.Essential Job DutiesSupport product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentationEvaluate changes to products including changes to design, material, labeling, packaging, manufacturing process, and facilityAssess the impact of the product/process changes and determine regulatory pathway for US marketsPresent regulatory strategy and status in internal group settingsGather information from international counterparts for ROW regarding the impact of changes and work with international counterparts to coordinate global regulatory submissions/approvalsPrepare internal documentation, and prepare and submit regulatory filings including non-filing justifications (NFJ) and 510(k)sProvide oversight of third party agency testing (UL, EMC, biocompatibility, sterilization) as requiredPerform other duties as required#J-18808-Ljbffr

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