Controllo Qualita jobs in Italy

Certexe is a new independent organization aiming to provide high‑quality conformity assessment, certification, and regulatory support services for medical devices and related technologies.

The company is actively pursuing Notified Body accreditation under Regulation (EU) 2017 / 745 (MDR), with a mission to ensure safety, innovation, and compliance through rigorous technical expertise, transparent processes, and continuous improvement.

We are seeking a highly qualified Deputy Technical Director / Scheme Manager to support the Technical Director in leading the Technical Department for Medical Devices Regulation (EU) 2017 / 745 (MDR).

This role is critical in ensuring the successful completion of the Notified Body accreditation process and in contributing to the effective management of certification operations and technical activities under MDR.

The Deputy Technical Director will work closely with the Technical Director and act as their deputy, taking on delegated responsibilities for managing technical personnel, overseeing conformity assessments, and ensuring compliance with applicable regulatory and quality standards.

Once the accreditation is obtained, the Scheme Manager will be responsible for the coordination and communication of conformity assessment teams, review and decision‑making of certification processes, and overall technical management of the MDR scheme.

• Support the Technical Director in managing all technical activities related to MDR accreditation and certification processes.
• Assist in the drafting, preparation, and review of technical documentation for the accreditation application.
• Coordinate with the Quality Manager and Technical Department to ensure alignment with internal processes and regulatory requirements.
• Contribute to the selection, qualification, and continuous competence evaluation of technical personnel involved in certification activities.
• Act as deputy to the Technical Director for the coordination, supervision, and organization of technical operations and assessments under MDR.
• Ensure the correct application of relevant harmonized standards and regulatory requirements throughout the certification process.
• Participate in internal audits, technical reviews, and the management of complex or critical cases.

• Coordinate and communicate with conformity assessment teams throughout the certification lifecycle.
• Perform assessment of client certification applications, ensuring technical adequacy and regulatory compliance.
• Conduct final reviews and act as decision‑maker in the certification process.
• Oversee all technical activities and personnel related to the MDR scheme.

• Educational background: University degree in a relevant medical, technical, or scientific discipline (e.g. Medicine, Pharmacy, Engineering, or other relevant sciences) providing a strong basis for the authorization of applicable MDR codes (MDA, MDN, MDS).
• Professional experience: Minimum four (4) years of professional experience in the field of healthcare products or related activities, such as manufacturing, auditing, or research.
• Specific device experience: At least two (2) of these four years must be directly related to the design, manufacture, testing, or clinical use of medical devices corresponding to the MDR codes for which authorization is sought, as listed below :
• MDA : 0203, 0204, 0305
• MDN : 1202, 1203, 1204, 1208, 1209, 1211, 1212, 1213
• MDS : 1001, 1005, 1008, 1009, 1010, 1011, 1012
• Regulatory knowledge: Comprehensive understanding of Regulation (EU) 2017 / 745, including conformity assessment procedures and technical documentation requirements.
• Standards competence: Proven working knowledge of ISO 13485, ISO 14971, ISO / IEC 17020, and ISO / IEC 17021, as applicable to MDR conformity assessment.
• Accreditation and conformity assessment experience: Demonstrated experience with MDR accreditation processes or equivalent schemes within a Notified Body or regulatory organization.
• Leadership and coordination skills: Proven ability to lead, organize, and coordinate multidisciplinary technical teams involved in conformity assessment and certification decision‑making.
• Language proficiency: Excellent command of English, both written and spoken.

• Qualification as assessor or technical expert under MDR for one or more of the above‑listed device codes.
• Qualification as a lead or internal auditor for ISO 9001 and ISO 13485 quality management systems.
• Experience in conducting or reviewing technical documentation and conformity assessments under MDR.
• Experience in the coordination of product reviewers and technical experts within a Notified Body structure.
• Proven involvement in technical reviews and certification decision‑making processes under MDR.

• A senior technical leadership role , reporting directly to the Technical Director.
• A highly competitive salary package.
• Flexible, primarily remote work model with regular coordination meetings.
• The opportunity to contribute to the creation and management of a Notified Body , participating in strategic, technical, and organizational activities from the ground up.