Especialista de Cumplimiento Regulatorio (ISO 13485)

Review and update of EU MDR/IVDR Technical Files and support to the RA mailbox regarding Change Orders, product related questions, complaints and non-conformities, etc. for sites in Tijuana, Monterrey and Roskilde.

• Work for regulatory activities in cooperation with the existing RA team and Sr RA Manager
• Support product development by facilitating globally focused regulatory strategies to drive market access.
• Draft regulatory plans and verification reports to ensure products meet regulatory requirements in all target market regions.
• Responsible for updating the CE technical files for medical products.
• Participate in and ensure follow up on customer requests in the RA mailbox.
• Review and approve product development reports, non-conformance reports, product changes, label content and new product data.
• Provide general quality support to the organization e.g. TrackWise, complaint, observations, CAPA, NC, CO’s, product regi...