RCC-IVDR Committee Member

We're looking for RCC-credentialed professionals interested in joining the RCC-IVDR Committee. These volunteers will be responsible for the development and administration of the RCC-IVDR certification exam. The committee ensures the fairness, relevance, and quality of the RCC-IVDR exam.

Responsibilities:

• Develop examinations based on the content outline, ensuring appropriate and accurate test questions and adherence to 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.

Eligibility Requirements:

• Current RCC holder or meet RCC eligibility requirements.

RCC Eligibility Requirements:

• Educational Pathway: Bachelor’s, Master’s, or Doctorate Degree in medicine, pharmacy, engineering, or related sciences + 1 year of regulatory-related experience with medical devices or in vitro diagnostics medical devices, OR
• Experience Pathway: 4 years of regulatory-related experience with medical devices or in vitro diagnostics medical devices.
• Regulatory-related experience may include quality assurance, quality control, clinical research related to the approval of health products, or health product project management.
• Minimum of one year of experience with EU medical device regulations.
• Experience in the PRRC role or working with individuals in the PRRC role as it relates to IVDR.
• Attend three virtual committee meetings per year and mandatory participation in both virtual and in-person item writing and exam assembly meetings, with one session conducted virtually and one in person.
• Individuals in this role cannot take the RCC during their tenure and will be restricted from doing so for a period afterward.