View Our Website View All Jobs

Senior Specialist/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 and Specialists that 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


  • 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


  • 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

Apply with Indeed
Attach resume as .pdf, .doc, .docx, .odt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file