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 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