*Role: QARA – Risk Management* *Location: Plymouth, Minnesota*
*Job Description:* The Clinical Subject Matter Expert (SME) will be responsible for the clinical support of device risk management activities at Smiths Medical. SME will have the following responsibilities: · Review and approval of the clinical workflow definitions for the subject devices · Identification of the clinical hazards and associated harms for the subject devices · Estimation of the severity and probability of occurrence for the clinically related hazardous situation · Development of the clinical benefit statements for the subject device *Key skills and experience:* · A degree in a clinical related field (RN, MD) · 10 years of clinical experience *Additional skills (Desirable)* · Understanding of device development in an FDA regulated environment · Experience with ISO 14971 risk management activities · Experience with the post market medical device support (complaint or risk analysis) Best Regards, *Sumit Singh* | SYSMIND, LLC Phone: 609-897-9670 x 2192 Email: sum...@sysmind.com Website: sysmind.com Hangout: sumit.int...@gmail.com Address: 38 Washington Road, Princeton Junction, NJ 08550 -- You received this message because you are subscribed to the Google Groups "SAP Workflow" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-workflow+unsubscr...@googlegroups.com. To post to this group, send email to sap-workflow@googlegroups.com. Visit this group at https://groups.google.com/group/sap-workflow. For more options, visit https://groups.google.com/d/optout.