Note: You must be logged in to apply for this opportunity. Click the "log in" button at the top right to log in. Don't have an account? Click here to create one.
RAPS is seeking volunteers with experience in regulatory affairs for medical devices to help develop the Regulatory Compliance Certification (RCC) programs as part of the RCC-MDR committee.
The RCC-MDR Committee is responsible for the development and administration of the RCC-MDR certification exam. The committee ensures the fairness, relevance, and quality of the exams. Committee members will be appointed to an initial term varying from 1-3 years with an option to renew for a three-year term.
The RCC-MDR Committee has the following responsibilities:
Develop the examinations based on the content outline, ensuring appropriate and accurate test questions and adherence to the distribution requirements.
Review and revise test questions submitted for inclusion into the question pool, maintaining content and structural integrity.
Revise test questions as necessary to align with the changing regulatory environment.
Serve as the expert panel for determining the cut score.
Maintain confidentiality of specific examination content through an annual confidentiality agreement.
To be eligible to serve on the RCC-MDR Committee, regulatory professionals must meet the following requirements:
Current RCC holder or meet RCC eligibility requirements
Minimum of one year of experience with EU medical device regulations
Attend three virtual committee meetings per year
Mandatory participation in both virtual and in-person item writing and exam assembly meetings, with one session conducted virtually and one in person.
Please note: individuals in this role cannot take the RCC during their tenure and will be restricted from doing so for a period afterward.
The RCC is RAPS' regulatory credential intended for individuals who want to demonstrate their knowledge of European medical device or IVD regulations. Learn more here.
Leeann Manlove
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
raps@raps.org+1 301 770 2920
JoinMy RAPS DashboardLearn More
About UsTerms of UsePrivacy Policy