Role of RA Specialist in the Design Process
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:
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
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.
There is no prerequisite knowledge required for this course; all areas of expertise are welcome.