We are looking for multiple MDR/IVDR Product Assessors with focus on Software Product Assessor to secure that the devices that we certify are efficient, safe, and meet the European requirements. Your job includes Identification of requirements, compliance assessment based on technical documentation, and acting as an expert in MD/IVD and SW compliance topics.
Job listings
Ergomed is seeking Regulatory Affairs professionals experienced in managing global complex clinical studies. The role involves leadership and functional representation for projects, managing SSU/regulatory tasks, and ensuring compliance with standards. It requires preparing regulatory information for submissions to FDA, EMA, and national authorities, and providing expert advice to clients, plus training junior staff.
An exciting new role with ICON within our regulatory team working on high profile Pharma projects. The Regional CTA Submission Manager (CTA-SM) is accountable for working with contributing to business lines to lead operational submissions execution for designated CTAs and may operate as regulatory operational Subject Matter Expert for EU CTR.