Sr QARA Specialist
4 days onsite EDUCATION AND EXPERIENCE
• Education Title: Degree in a technical discipline (Biomedical Engineering or similar)
•
Experience:
Two years of experience in a similar position is preferred MAIN ACTIVITIES
• Objective/Mission: The core activity of the DOCUMENTATION & CERTIFICATION SPECIALIST involves the processing, issuance, cataloging, and archiving of technical documentation. Activities:
• Analysis and interpretation of applicable regulations (MDR 2017/745, IVDR if applicable, directives/harmonized standards)
• Monitoring and updating of harmonized standards
• Drafting, reviewing, and maintaining the Technical Documentation relative to autoclaves
• Organizing Notified Body (NB) verifications for CE, PED, etc.
• Verifying compliance with General Safety and Performance Requirements (GSPR)
• Coordinating contributions from R&D;, PL, Quality, Clinical, and Production for PMS and PMCF activities
• Documentation management, including: Risk Management (ISO 14971), Usability engineering (IEC 62366), Medical device software (IEC 62304), Electrical safety and EMC (IEC 60601 series)
• Preparing and submitting files for CE marking and interfacing with the Notified Body
• Supporting audits and inspections
• Managing observations, non-conformities, and requests for clarification (NC, CAPA)
• Registering devices and the company in EUDAMED
• Supporting Post-Market Surveillance (PMS) activities
• Serving as the point of reference for managing inquiries regarding dangerous goods (DGR) Collaboration with Quality Assurance for:
• ISO 13485
• Change Control management
• Supporting internal training on regulatory aspects
• Reviewing company procedures with certification impacts
• Collaborating with REG (Regulatory Affairs) for extra-EU registration submissions
• Managing Purchase Requisitions (RDA) with corresponding updates in ERP/management systems
• Travel availability: No
• Internal / external relations: Interacts internally with technical area personnel
• Decision-making autonomy: Low
• Level of complexity: Medium TECHNICAL COMPETENCIES
• Language
skills:
Good English
• IT
skills:
Office Suite and Adobe Suite
• Specialized knowledge: Technical and professional skills required for the position
• Health and safety: [Left blank in original text] BEHAVIORAL COMPETENCIES
• Teamworking
• Guiding
• Proactivity
• Results Orientation
• Accuracy
• Availability
• Problem solving
• Innovation and Openness
• Education Title: Degree in a technical discipline (Biomedical Engineering or similar)
•
Experience:
Two years of experience in a similar position is preferred MAIN ACTIVITIES
• Objective/Mission: The core activity of the DOCUMENTATION & CERTIFICATION SPECIALIST involves the processing, issuance, cataloging, and archiving of technical documentation. Activities:
• Analysis and interpretation of applicable regulations (MDR 2017/745, IVDR if applicable, directives/harmonized standards)
• Monitoring and updating of harmonized standards
• Drafting, reviewing, and maintaining the Technical Documentation relative to autoclaves
• Organizing Notified Body (NB) verifications for CE, PED, etc.
• Verifying compliance with General Safety and Performance Requirements (GSPR)
• Coordinating contributions from R&D;, PL, Quality, Clinical, and Production for PMS and PMCF activities
• Documentation management, including: Risk Management (ISO 14971), Usability engineering (IEC 62366), Medical device software (IEC 62304), Electrical safety and EMC (IEC 60601 series)
• Preparing and submitting files for CE marking and interfacing with the Notified Body
• Supporting audits and inspections
• Managing observations, non-conformities, and requests for clarification (NC, CAPA)
• Registering devices and the company in EUDAMED
• Supporting Post-Market Surveillance (PMS) activities
• Serving as the point of reference for managing inquiries regarding dangerous goods (DGR) Collaboration with Quality Assurance for:
• ISO 13485
• Change Control management
• Supporting internal training on regulatory aspects
• Reviewing company procedures with certification impacts
• Collaborating with REG (Regulatory Affairs) for extra-EU registration submissions
• Managing Purchase Requisitions (RDA) with corresponding updates in ERP/management systems
• Travel availability: No
• Internal / external relations: Interacts internally with technical area personnel
• Decision-making autonomy: Low
• Level of complexity: Medium TECHNICAL COMPETENCIES
• Language
skills:
Good English
• IT
skills:
Office Suite and Adobe Suite
• Specialized knowledge: Technical and professional skills required for the position
• Health and safety: [Left blank in original text] BEHAVIORAL COMPETENCIES
• Teamworking
• Guiding
• Proactivity
• Results Orientation
• Accuracy
• Availability
• Problem solving
• Innovation and Openness