*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 "US_IT.Groups" group. To unsubscribe from this group and stop receiving emails from it, send an email to us_itgroups+unsubscr...@googlegroups.com. To post to this group, send email to us_itgroups@googlegroups.com. Visit this group at https://groups.google.com/group/us_itgroups. For more options, visit https://groups.google.com/d/optout.
