Ivdr Product Assessor

3 giorni fa

Milano, Italia Tn Italy A tempo pieno

col-wideJob Description:

Job Description

As anIVDR Product Assessor, you will use your skills as an expert inclinical diagnostic technologiesto ensure that patients across Europe have access to safe and effective diagnostic tests. Join our rapidly growing team of regulatory professionals in helping the European healthcare ecosystem navigate the challenging transition to the newEuropean In Vitro Diagnostics Regulation.
Your role will be toassess in-vitro diagnostic medical devicesfor strict compliance with the relevant European laws (EU IVDR; Regulation 2017/746). You key task will be carrying out reviews of the manufacturers'technical documentationas part of theCE markingprocess. This will require a keen interest in and deep understanding of the product technologies being assessed, knowledge of the clinical application of the devices, as well as a keen eye for detail.
Key Responsibilities:
Conduct technical file reviewsagainst theEU In-vitro Diagnostics RegulationforClass A sterile, Class B and Class Cdevices within a defined timeframe, by verifying compliance of technical documentation submitted by manufacturers against the regulatory requirements.
Identify, document and seek to rectify instances where device technical files deviate from compliance with applicable requirements under theIVDR.
Provide support forCE marking activitieswithin SGS, contribute to thetraining and qualification of junior staff, and develop comprehensive training materials.
Communicate effectively with team members, clients, and other stakeholders regardingproduct assessments, working diligently to minimize regulatory risks associated within vitro diagnostic device certification.
Expand and keep up-to-date your knowledge of relevanttechnologies, regulations, international standardsand best practice guidance documents.

Qualifications
We are seeking an experienced candidate with:
At least4 years of professional experiencewithin the domain of healthcare products or in related activities. This may include for example roles in design and development, manufacturing, auditing, relevant academic research, or work in a clinical these, a minimum of2 yearsshould involve direct engagement in thedesign, manufacture, testing or utilization of specific in-vitro diagnostic devices and technologies, or relevant scientific research
Knowledge encompassing a range ofIVR/IVS/IVP/IVD competence codesfor IVDR, as defined in Commission implementing regulation (EU) 2017/2185
Degreeor equivalent qualification in a relevant technical discipline such asmedicine, engineering, biomedical science, microbiology or biochemistry.
Proficient communication skillsusing modern electronic platforms.
Strongwritten English skills, as reports will be reviewed and queried in English.
Demonstrated skills inindependent learning.
Desirable Skills:
Direct experience withmedical device development life cycle processes, regulatory submissions and relevant standards such asISO 13485 and ISO 14971.
Experience withclinical studies and clinical performance evaluationof in-vitro diagnostic devices.
A broad base of experience covering a variety of different diagnostic assay types and technologies.
Prior experience in conductingproduct technical documentation assessmentsfor anotherConformity Assessment Body / Notified Body(technical file reviewer or equivalent role) would be considered advantageous.
An in-depth knowledge of theEuropean regulatory framework on medical devicesis highly advantageous, but is not required to apply for this role as on-the-job training will be provided.

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