- Regulatory Compliance: Review and assess technical documentation, including design dossiers, technical files, and risk management files, to ensure conformity with applicable EU regulations such as MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation).
- Product Classification: Expertly classify medical devices and in vitro diagnostic medical devices (IVDs) according to their intended use and risk classification, in alignment with EU regulations.
- Technical Expertise: Provide technical expertise and guidance to manufacturers regarding regulatory requirements, standards, and best practices for medical device development, testing, and documentation.
- Audit and Assessment: Conduct on-site and remote audits of manufacturers' quality management systems, production processes, and technical documentation to verify compliance with regulatory requirements and standards.
- Risk Management: Evaluate risk management processes and documentation to ensure proper identification, assessment, and mitigation of risks associated with medical devices throughout their lifecycle.
- Experience: Minimum of 3 years of experience in R&D within the medical device industry.
- Fluent in German and English.
- Regulatory Knowledge: In-depth knowledge of EU medical device regulations (MDR, IVDR), ISO 13485, and other relevant standards and guidelines.
- Technical Competence: Strong technical understanding of medical device design, development, manufacturing processes, and risk management principles.
- Communication Skills: Excellent verbal and written communication skills in German and English, with the ability to effectively communicate complex technical concepts to diverse stakeholders.
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Beschreibung
A global notified body in the medical device industry is looking for fully remote Product Specialist.
P.s, you need to have R&D experience in the medical device industry to be qualified for this role.
Responsibilities
Requirements
Please apply if you're interested.
