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:

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BEHAVIORAL COMPETENCIES

- Teamworking

- Guiding

- Proactivity

- Results Orientation

- Accuracy

- Availability

- Problem solving

- Innovation and Openness

📌 Sr QARA Specialist (Bologna)
🏢 SARACA
📍 Bologna