View Our Website View All Jobs

Engineer - Regulatory

Job Summary:  Make your impact today and join the R&Q Team. We are looking to add to our team of Regulatory Engineers to work with our clients domestically and internationally! 

Key Areas of Demonstrated Competence: 5 R&Q Knowledge Areas

Depending on the individual client assignment(s), the Engineer may perform the following essential duties:

  • Provides daily regulatory and quality hands-on support to clients under the direct supervision of an experienced consultant
  • Contributes in the drafting of worldwide regulatory strategies and worldwide regulatory submissions
  • Contributes with Quality System Development programs as well as Quality System improvement programs
  • Contributes to quality audits and audit preparation of clients
  • Contributes to design assurance activities: safety risk management, usability, design verification and design validation
  • Contributes to process validation and other related quality manufacturing tasks
  • Contributes in the definition of supplier quality specifications and other supplier qualification activities
  • Contributes to supplier audits
  • Conducts post-market surveillance activities including complaint/MDR handling, design history file remediation, and other remediation activities under supervision
  • Coordinates recall activities as directed by an experienced consultant

 

Project Resource Responsibility

  • Responsible for completing work activities, as defined by the project lead, on schedule and in accordance with the allotted hours
  • Communicates project risk and issues to the project lead in a timely fashion

Sales and Marketing

  • Builds relationships with customers and identifies new customer needs and requirements
  • Develops and cultivates a strong medical device industry network to provide connections to the Sales Team
  • Participates in marketing activities as assigned by the Marketing Team

Education

  • Bachelor level degree in engineering or chemistry, physics, biology or related life science, advanced degree preferred
  • 2-5 years related work experience.
  • 1-3 years of experience in the medical device industry required
  • Consulting experience preferred

Requirements

  • Working knowledge of FDA Quality System Regulations required
  • Computer skills required – Microsoft Office applications; statistical data analysis preferred
  • Report writing skills required
  • Must be willing to travel, up to 50%

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

 

 

Read More

Apply for this position

Required*
Apply with Indeed
Attach resume as .pdf, .doc, or .docx (limit 2MB) or Paste resume

Paste your resume here or Attach resume file

150