RAPS is seeking qualified volunteers to participate in RCC item writing in support of the Regulatory Compliance Certification (RCC) program. This opportunity supports examination development aligned with the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Regulation (IVDR) and the Professional Responsible for Regulatory Compliance (PRRC) role outlined in Article 15.
Volunteers will contribute to the review and refinement of exam questions to ensure continued accuracy, relevance, and alignment with the evolving regulatory landscape. This is a valuable opportunity to support the profession while gaining insight into exam development activities.
Participation Requirements
This opportunity requires an active RCC certification and the ability to attend two required virtual meetings, each held 11:00 a.m.–1:00 p.m. ET, and to complete item‑writing assignments outside of live meetings.
- Item‑writing session: July 14, 2026 (virtual)
- Follow‑up meeting (virtual):
- RCC‑MDR: September 29, 2026 or
- RCC‑IVDR: October 1, 2026
- Additional assignments: Completed virtually outside of live meetings
The estimated total time commitment is approximately 5–6 hours. No travel is required. Volunteers who meet all requirements and complete the assignment will be eligible to earn 5 RCC recertification credits.
Responsibilities & Qualifications
- Write, review, and revise RCC exam questions for inclusion in the question pool, ensuring technical accuracy, clarity, and alignment with current EU MDR and/or EU IVDR requirements
- Participate in virtual discussions and complete assigned follow‑up work while maintaining confidentiality of all examination content
- Hold an active RCC certification in good standing
- Regulatory experience with EU MDR and/or EU IVDR is required; professionals at all levels of regulatory experience are encouraged to apply