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Posted: February 02, 2017
RQMIS Inc. is a fast growing, medical device/biotechnology consultancy with a focus on regulatory strategy /submissions, clinical study design/management and quality systems design/compliance/auditing. We are looking for a Regulatory Affairs Project Manager who is a Subject Matter Expert (SME) in Regulatory Strategy and Submissions. This individual will be the primary contact and support person for our clients when developing and implementing activities that will satisfy regulatory authorities to gain market clearance in the United States and the EU.
The overall responsibilities of this position include identifying the necessary product specifications, standards compliance requirements, preclinical and clinical testing and labeling for premarket submissions in the US and the EU. Experience in regulatory project management during the design control process is essential. Bachelor degree in engineering or science is required.