PbAbout the Role /b /ppbCertexe /b is a new independent organization aiming to provide high-quality bconformity assessment, certification, and regulatory support services /b for medical devices and related technologies. /ppThe company is actively pursuing bNotified Body accreditation under Regulation (EU) 2017/745 (MDR) /b, with a mission to ensure safety, innovation, and compliance through rigorous technical expertise, transparent processes, and continuous improvement. /ppbr/ppbAbout the Role /b /ppWe are seeking a highly qualified bDeputy Technical Director / Scheme Manager /b to support the Technical Director in leading the Technical Department for Medical Devices Regulation (EU) 2017/745 (MDR). /ppThis 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. /ppThe 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. /ppOnce 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. /ppbr/ppbKey Responsibilities /b /pulliSupport the Technical Director in managing all technical activities related to MDR accreditation and certification processes. /liliAssist in the drafting, preparation, and review of technical documentation for the accreditation application. /liliCoordinate with the Quality Manager and Technical Department to ensure alignment with internal processes and regulatory requirements. /liliContribute to the selection, qualification, and continuous competence evaluation of technical personnel involved in certification activities. /liliAct as deputy to the Technical Director for the coordination, supervision, and organization of technical operations and assessments under MDR. /liliEnsure the correct application of relevant harmonized standards and regulatory requirements throughout the certification process. /liliParticipate in internal audits, technical reviews, and the management of complex or critical cases. /li /ulpbr/ppbPost-Accreditation Responsibilities /b /pulliCoordinate and communicate with conformity assessment teams throughout the certification lifecycle. /liliPerform assessment of client certification applications, ensuring technical adequacy and regulatory compliance. /liliConduct final reviews and act as decision-maker in the certification process. /liliOversee all technical activities and personnel related to the MDR scheme. /li /ulpbr/ppbMandatory Requirements /b /ppCandidates must meet ball /b of the following criteria: /pullibEducational background: /b 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). /lilibProfessional experience: /b Minimum bfour (4) years of professional experience /b in the field of healthcare products or related activities, such as manufacturing, auditing, or research. /lilibSpecific device experience: /b At least btwo (2) of these four years /b must be directly related to the bdesign, manufacture, testing, or clinical use of medical devices /b corresponding to the bMDR codes for which authorization is sought /b, as listed below: /lilibMDA: /b 0203, 0204, 0305 /lilibMDN: /b 1202, 1203, 1204, 1208, 1209, 1211, 1212, 1213 /lilibMDS: /b 1001, 1005, 1008, 1009, 1010, 1011, 1012 /lilibRegulatory knowledge: /b Comprehensive understanding of bRegulation (EU) 2017/745 /b, including conformity assessment procedures and technical documentation requirements. /lilibStandards competence: /b Proven working knowledge of bISO 13485 /b, bISO 14971 /b, bISO/IEC 17020 /b, and bISO/IEC 17021 /b, as applicable to MDR conformity assessment. /lilibAccreditation and conformity assessment experience: /b Demonstrated experience with bMDR accreditation processes /b or equivalent schemes within a Notified Body or regulatory organization. /lilibLeadership and coordination skills: /b Proven ability to lead, organize, and coordinate multidisciplinary technical teams involved in conformity assessment and certification decision-making. /lilibLanguage proficiency: /b Excellent command of bEnglish /b, both written and spoken. /li /ulpbr/ppbPreferred Additional Qualifications /b /pulliQualification as bassessor or technical expert /b under MDR for one or more of the above-listed device codes. /liliQualification as a blead or internal auditor /b for bISO 9001 /b and bISO 13485 /b quality management systems. /liliExperience in conducting or reviewing btechnical documentation and conformity assessments /b under MDR. /liliExperience in the bcoordination of product reviewers and technical experts /b within a Notified Body structure. /liliProven involvement in btechnical reviews /b and bcertification decision-making processes /b under MDR. /li /ulpbr/ppbWe Offer /b /pulliA bsenior technical leadership role /b, reporting directly to the Technical Director. /liliA bhighly competitive salary package /b. /lilibFlexible, primarily remote work model /b with regular coordination meetings. /liliThe opportunity to contribute to the bcreation and management of a Notified Body /b, participating in strategic, technical, and organizational activities from the ground up. /li /ul