Regulatory Affairs Consultant III

Description:
 
EU MDR Project Support: 
 To succeed in this role, you should have the following skills and experience 
 • Bachelor’s degree in science,engineering/technology or related field, Master’s degree preferred. 
 • Min 7+ years of experience with working knowledge of global medical device regulations, requirements 
 • Viewed as an expert within EU Regulations, with proven experience in implementation and use of EU Medical Device Directive, In Vitro Diagnostic Directive, Low Voltage Directive and Radio Equipment Directive and knowledge and interpretation of the differences in the EU MDR Medical Device Regulations. 
 • Knowledge and expertise in Quality Management Systems and Risk Management Standards – ISO 13485 and ISO 14971. 
 • Strong executive presence; ability to influence multiple levels of stakeholders and management 
 • Demonstrated track record of team leadership, building teams, relationship management, and business development, including virtual teams 
 • Strong communication, interpersonal and presentation skills; detail-oriented • Proven experience in a matrix management of multiple operations 
 • Ability and willingness to travel both domestically and internationally up to 25% of the time. 

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