*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

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