Course Description

Role of RA Specialist in the Design Process

Course Description:

This course focuses specifically on the responsibilities of the Regulatory Affairs (RA) specialist within the medical device manufacturer’s design process.

It features a comprehensive illustration of the RA specialist’s role in the following areas:

  • Design control
  • Regulatory documentation
  • Submissions
  • Product launch
  • Design changes

Watch the Course Trailer:



Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Identify the RA specialist’s function in the manufacturer’s design process, including initial design, documentation, submissions, and launch
  • Recognize the importance of the RA specialist in the following phases:
    • Early on in the design process
    • Throughout the device’s development
    • Up until the product launch

Who Should Enroll:

Regulatory Affairs Associate, Quality Assurance Associate, Quality Assurance Engineer, Manufacturing Engineer, Supply Manager, Purchasing Manager, Design Engineer, Validation Engineer, Notified Body Auditor, Regulator, Electrical Safety Engineer, Internal Auditor, R&D Engineer, Clinical Affairs Director, Clinical Project Manager, and Human Resource Manager , and those interested in learning about the typical roles and responsibilities of RA specialists in the design process are all encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

There is no prerequisite knowledge required for this course; all areas of expertise are welcome.

Subject Matter Expert:
Adrienne Lenz

40 min

Related resources:

Case studies:

Basic Account: € 118.00
Premium Account: € 89.00

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