Fachzertifizierer für Medizinprodukte (all genders)

Technical Documentation Reviewer

Your Role

Your Responsibilities

• Evaluation of technical documentation (TD-review) of medical devices under MDR.
• Conducting audits according to MDR, ISO 13485, and MDSAP if applicable.
• Assessment of changes to products and quality management systems, SSCPs, PSURs, and vigilance within the framework of continuous monitoring.
• Creation of audit programs and sample plans, assignment of resources, verification of applications, classification, coding, etc.
• Participation in conformity assessment procedures, especially for complex or novel medical devices.
• Technical exchange with internal and external experts (e.g., clinical experts, risk assessors).
• Support for authority inquiries, possibly participation in inspections by ZLG, DAkkS, and SCC.
• Support of internal improvement measures.
• Final approval of medical devices.

Your Profile

• Completed studies in a relevant field (e.g., medical technology, biomedicine, engineering, natural sciences).
• Several years of professional experience (> 4 years) in the development, manufacturing, testing, or quality assurance of active or non-active medical devices.
• Ideally, more than 10 years of professional experience as an auditor and/or product evaluator at a designated body for the MDR regulation (EU) 2017/745. Your professional experience demonstrably covers a broad range of medical devices (MDA- and/or MDN-codes) and technologies (MDT-codes).
• In-depth knowledge of MDR, ISO 13485, ISO 14971, ISO 10993, IEC 62304, IEC 62366-1, IEC 60601, ISO 14155, MDSAP documents, as well as other regulatory requirements, MDCG guidelines, and product standards.
• Recognized and demonstrable qualifications as a lead auditor for MDR, ISO 13485, and ideally MDSAP.
• Proficient ability to evaluate complex technical and clinical matters.
• Fluent German and English skills in speech and writing.
• High level of personal responsibility, objectivity, and professional communication.
• Willingness to travel internationally (as needed)