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Engineer - Regulatory (Contract Role)

Job Summary: Make your Impact today with R&Q. We have an immediate need to join our team as a Project Employee. This is estimated to last at least 6 months working in the Regulatory Department for this exciting Med Device Organization that is changing patients lives.  The ideal candidate will have a few years of US reg experience, and ideally a little EU experience as well for tech file remediation activities.  This will require on site work at our Client's facility in the New Jersey area. Opportunities to join our team as a Full Time Consultant are available for candidates that are willing to relocate upon successful completion of this project. 

Education/Work Experience

  • Bachelor level degree in engineering or chemistry, physics, biology or related life science 
  • 2-5 years related work experience
  • 1 year of experience in the medical device industry required
  • Consulting experience preferred

Requirements

  • Working knowledge in one or more of the following areas is required:
  • Quality System Regulations (FDA, ISO13485, EU Medical Devices Directive, Canadian MDR)
  • Market Clearance and strategy (510K, EU Technical Files, Canadian licensing)
  • Design controls, DHF Development, and related standards especially International Electrical Safety, Biocompatibility, and ISO 10993 Software Development and Validation per EN 62304
  • Computer skills required –Microsoft Office applications; statistical data analysis
  • Excellent report writing skills required

Key Behaviors

Action-Oriented, Approachable, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

 

 

 

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