- 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 ACTIVITIESObjective/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 COMPETENCIESLanguage 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 COMPETENCIESTeamworking

- Guiding

- Proactivity

- Results Orientation

- Accuracy

- Availability

- Problem solving

- Innovation and Openness

📌 Senior QARA Expert (Bologna)
🏢 SARACA
📍 Bologna