In-house Clinician, Global Medical Devices

3 giorni fa


Roma, Italia SGS A tempo pieno

**Company Description**
We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

As In-house Clinician, you are a key member of the clinical team within a Notified Body, which acts to ensure the safety and efficacy of in-vitro diagnostic medical devices available in Europe. You will act as a key decision maker in ensuring that IVD devices sold in the EU provide relevant clinical benefits, minimise risks to the patients and reflect the state of the art in clinical diagnostics.

You will work together with a group of clinicians and specialized product reviewers for the conformity assessment process of IVD devices in accordance with the EU In-vitro Diagnostic Medical Devices Regulation 2017/746. You will support the technology experts on the team with your clinical knowledge to provide clinical oversight and ensure that our assessment of the clinical aspects of IVD devices complies with the requirements of the IVDR.

**Specific Responsibilities**:

- Act as the primary clinical expertise within SGS In-vitro Diagnostic Medical Device certification activities
- Review and scientifically challenge the clinical data contained within the clinical performance evaluation, and any associated clinical investigations
- Coordinate the involvement of external clinical experts in the assessment process - deciding when external expertise is required, guiding the experts in their tasks and evaluating the results
- Draw up records and reports regarding clinical assessment, and make recommendation to the notified body’s decision makers
- Develop, update and maintain appropriate training packages (with a focus of clinical evaluation assessments) for clinical experts and other team members
- Offer appropriate clinical input into client queries and meetings

**Qualifications** Essential**:

- Professional experience in the field of clinical diagnostics. This may include experience as a physician, clinical pathologist, clinical scientist, clinical biochemist, biomedical scientist, clinical diagnostics laboratory manager, etc. Professional accreditation and/or active registration with relevant professional societies is highly advantageous
- University degree in a relevant domain
- At least two years of experience relevant to the generation and/or interpretation of performance data for in-vitro diagnostic assays in a clinical setting
- Fluent in English, reading and writing

**Desirable**:

- Knowledge of the EU in-vitro medical device regulation (IVDR) and related MDCG guidance
- Working experience in the IVD industry and knowledge of device clinical performance evaluation, such as verification and validation studies, clinical studies
- Experience with clinical investigations of in-vitro diagnostic assays or biomarker discovery studies
- A keen interest in medical device regulatory affairs



  • Roma, Lazio, Italia Cosmo Intelligent Medical Devices A tempo pieno

    Cosmo Intelligent Medical Devices is a leading division of Cosmo Pharmaceutical group, specializing in the development and integration of artificial intelligence in medical devices.We have developed unrivaled expertise in AI Med Tech business aspects such as medical device Hardware and Software design, healthcare Artificial Intelligence development, medical...


  • Roma, Italia SGS A tempo pieno

    **Company Description** We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. The Technical Training...


  • Roma, Lazio, Italia Cosmo Intelligent Medical Devices A tempo pieno

    Cosmo IMD Overview">Cosmo IMD is a leading division of Cosmo Pharmaceutical group, specializing in innovative medical devices integrating cutting-edge artificial intelligence.">The company has established itself as a pioneer in the AI Med Tech business, with expertise spanning multiple areas including medical device hardware and software design, healthcare...


  • Roma, Italia Soho House & Co. A tempo pieno

    **Who We Are** We are a collection of members' clubs, restaurants, hotels, workspaces and cinemas, catering to those in the film, media, fashion and creative industries. The company has unique ventures throughout the UK, USA, Canada, Europe and Asia, with new openings planned globally. Soho House is a space for its diverse membership and teams to connect,...


  • Roma, Italia Tailor&Fox Srl A tempo pieno

    Per il nostro Cliente, Azienda **Multinazionale** **Leader nel Settore dei Dispositivi Medici** e **Strumentazione Scientifica** con prodotti di alta qualità e un eccellente Customer Service, per il rafforzamento della propria struttura dell’Area Service, ricerchiamo il seguente profilo: **TEAM LEADER SERVICE**:**Medical...


  • Roma, Italia Soho House & Co. A tempo pieno

    **Who We Are** We are a collection of members' clubs, restaurants, hotels and cinemas, catering to those in the film, media, fashion and creative industries. The company has unique ventures throughout the UK, USA, Canada, Europe and Asia, with new openings planned globally. Soho House is a space for its diverse membership and teams to connect, grow, have...


  • Roma, Lazio, Italia Mcr International A tempo pieno

    About Mcr InternationalWe are a dynamic pharmaceutical industry startup seeking an experienced Global Oncology Medical Specialist to join our team in Italy. As a permanent employee, you will report directly to the Global Medical Director and be responsible for serving as the company's scientific expert.ResponsibilitiesServe as the company's scientific...


  • Roma, Lazio, Italia euraxess.ec.europa - Jobboard A tempo pieno 600 €

    About the Position">The BioRobotics Institute of Scuola Superiore Sant'Anna is seeking a highly motivated and skilled researcher to join our team as an Innovative Biomedical Devices Researcher. As part of our Intelli-Ingest Doctoral Network, you will be working on the design, testing, and performance assessment of advanced physical simulators for endoscopic...


  • Roma, Lazio, Italia Physiol A tempo pieno

    Job OverviewWe are seeking a Senior Mechanical Design Engineer to join our R&D Team in Italy, responsible for the design and development of mechanical systems and products for ophthalmic surgical devices.Key ResponsibilitiesDesign and develop medical device components, sub-assemblies and complete systems as well as associated test and fabrication...


  • Roma, Lazio, Italia Cosmoimd A tempo pieno

    Job DescriptionAs a Senior Systems Engineer at Cosmoimd, you will play a crucial role in supporting the production and maintenance of Intelligent Medical Devices.Key Responsibilities:Design and implement Linux-based tools to improve the production line efficiency.Manage and configure AWS Cloud services, including S3, IAM, and security policies.Implement...


  • Roma, Lazio, Italia Physiol A tempo pieno

    About the RoleAt PhysIOL, we're revolutionizing the future of vision by delivering innovative solutions for our physicians and patients. As a key member of our team, you'll play a critical role in driving high-impact research and development initiatives.Main ResponsibilitiesProvide technical leadership within new product development and sustaining...

  • Medical Advisor

    6 ore fa


    Roma, Italia ABBVIE A tempo pieno

    For our Rome Office, we are looking for a Medical Advisor for Gastroenterology Area, with following responsibilities: - In cooperation with affiliate / Area Medical teams, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects. - Establishes and approves scientific methods for...


  • Roma, Italia TFS HealthScience A tempo pieno

    **Join Our Team as a Medical Science Liaison (based in Milan)** **About this role** TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and...


  • Roma, Lazio, Italia euraxess.ec.europa - Jobboard A tempo pieno 600 €

    Job DescriptionWe are seeking a highly motivated Postdoctoral Researcher to join our team at the BioRobotics Institute of Scuola Superiore Sant'Anna. The successful candidate will work on the design, testing, and performance assessment of advanced physical simulators for endoscopic diagnostic and interventional procedures.About the ProjectThe Intelli-Ingest...

  • Product Specialist

    1 settimana fa


    Roma, Italia Aptiva Medical srl A tempo pieno

    **Aptiva Medical srl, distributore italiano di medical devices ricerca Sales & Technical Consultant.** **Principali mansioni**: - Supporto commerciale, tecnico e clinico alla rete vendita - Coordinamento e organizzazione del supporto tecnico di sala operatoria - Relazione con i clienti e principali KOLs - Sviluppo alla direzione commerciale per lo sviluppo...


  • Roma, Italia Pfizer, S.A. de C.V A tempo pieno

    MEDICAL COMPLIANCE ADVISOR - 12 MONTHS CONTRACT WITH RANDSTAD JOB PURPOSE The Medical Compliance Advisor supports all activities related to Medical Quality, Audit/Inspection Readiness, training, process improvements and Risk Mitigation, across Business Units for Pfizer Country Medical Operations. The Medical Compliance Advisor is expected to interact...


  • Roma, Italia Abbvie A tempo pieno

    **About AbbVie** For our Eye Care Division, we are searching for a Medical Advisor based in Rome, with following responsibilities: - In cooperation with affiliate / Area Medical teams, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects. - Establishes and approves scientific methods...

  • Area Manager

    6 ore fa


    Roma, Italia Wyser A tempo pieno

    Prestigioso Gruppo Multinazionale che sviluppa, progetta, produce, commercializza e vende soluzioni all'avanguardia in ambito medicale, ci ha incaricati di ricercare un: **Area Manager - Medical Device** **_ Lazio Abruzzo e Sardegna_** **_ Principali Responsabilità:_** - Sviluppare relazioni, reti e nuove opportunità di business orientate...

  • Medical Advisor, Italy

    1 settimana fa


    Roma, Italia Blueprint Medicines A tempo pieno

    **Location(s)**:**Rome, Italy **Level of position**:**Associate Director **Position type**:**70% Office-based, 30% Field-based (Or office-based with 30% business travel) **Reporting Line**:**The position reports to the Country Medical Lead **How will your role help us transform hope into reality?** The Medical Advisor role at Blueprint Medicines is a...

  • Medical Advisor

    2 giorni fa


    Roma, Italia Daiichi-Sankyo Europe A tempo pieno

    **r**oles and responsibilities** Medical Advisor is a medical affair professional with excellent scientific understanding and knowledge in oncology. She/He reports into the Local Medical Affairs Department. - Participate and be an active member in the country Medical and Brand teams in order to provide medical input into Brand Strategy - Is responsible to...