Clinical Affairs Consultant III

Location: Remote with 25% travel
 Duration: 6 Months
 
The Clinical Operations Specialist role will be responsible for performing Clinical Evaluations and writing/updating Clinical Evaluation Reports (CERs), associated documents, templates, and processes in compliance with MEDDEV 2.7.1 Rev. 4 and the European Union (EU) Medical Device Regulation (MDR). Your ability to interpret the current, new and changing requirements for clinical research, including use of product equivalency will ensure the proper clinical information about our products is available for use, contributing to successful transfers of research results to the business and proper compliance with MDR in the EU market. 
 
 We are looking for 
 M.Sc. degree preferred 
 5+ years of critical care experience as medical professional, preferably with cardiology experience in critical care settings 
 Minimum of 5 years direct experience performing clinical evaluations and writing CERs compliant with MEDDEV 2.7.1. 
 Knowledge and experience with Medical Devices Directive 93 / 42 /EEC 
 Knowledge and experience with MEDDEV 2.7.1 Clinical Evaluations 
 Knowledge and experience with MEDDEV 2.12-2 PMCF 
 Knowledge and experience with GHTF SG5/N2R8: Clinical Evaluation 
 Knowledge and experience with EN ISO 14155 Clinical Investigations 
 Knowledge and experience with ISO14971 Risk Management 
 Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment 
 Interest in and passion for research, bringing medical innovations to market and working in multidisciplinary teams 
 Good communication skills, written and verbal 
 Must be available to travel domestically approximately 25%, with occasional international travel 

Regards,
Vikas

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