Senior Remote Consultant

CMG MedDev; Madrid; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A medical device consulting firm is seeking a Senior Consultant to work remotely. The role involves defining device classifications, developing regulatory strategies, and preparing technical documentation. Ideal candidates have experience in the medical device industry and proficiency in EU/FDA regulations. Strong skills in risk analysis and knowledge of quality management systems are also required.

Formación

• Experience in medical devices, IVD, and MDSW.
• Proficiency in EU / FDA regulations (MDR, IVDR, 510k).
• Knowledge of quality management systems (QMS) like ISO 13485 and ISO 15189.

Responsabilidades

• Define device classification and regulatory strategy.
• Prepare and review technical documentation.
• Implement regulatory requirements and conduct risk analysis.

Conocimientos

Technical documentation

Risk analysis

Regulatory strategy development

Clinical services

Descripción del empleo

Company Description

At CMG MedDev, we specialize in tailor‑made solutions for medical devices, IVDs, MDSW, and AI, prioritizing safety and efficiency. We guide clients through regulatory frameworks, quality systems, and clinical research with a customer‑specific approach. Our services include regulatory affairs, quality management system implementation, medical writing, clinical services, approval and registration, and comprehensive training programs. This is a full‑time remote role for a MD / IVD / MDSW Senior Consultant. The consultant will be responsible for device definition and classification, regulatory strategy development, and the preparation and review of technical documentation. Day‑to‑day tasks include performing risk analysis, implementing regulatory requirements such as MDR, IVDR, and 510k, and managing conjunctions with ISO standards like IEC 62304. Experience in medical devices, IVD and MDSW

Proficiency in technical documentation, risk analysis, and implementation of EU / FDA regulations (MDR, IVDR, 510k)

Knowledge of quality management systems (QMS) according to ISO 13485, ISO 15189, ISO 9001, and other relevant standards

Expertise in medical writing, including labeling, IFU, CEP / CER, and PMSP / R

Strong skills in clinical services, including study design, ethics submissions, monitoring, and biostatistics

Ability to work independently and remotely

Experience in the medical device industry and familiarity with quality systems, regulatory requirements, and clinical research methodologies