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