Clinical Product Specialist Structural Heart - Affluent Medical

Clinical Product Specialist Structural Heart

JOB DESCRIPTION

DESCRIPTION OF EXECUTION OF KEYS MISSIONS
  • Training of new medical centers in the context of the clinical study: Simulands, IMRR
  • Patients’ eligibility evaluation within the context of clinical study using dedicated assessment software (e.g., Pie Medical 3mensio Structural Heart).
  • Preparation of the Advisory panel (review of eligibility criteria of submitted cases)
  • Ad-hoc support to the clinical team in product-related training and technical questions and issues.
  • Case support: attending cases, crimping of the valve, Medical Training on sites with Simulands, OR setup logistics, Proctor’s engagement
  • Support Clinical Sites selection ( assess OR facilities, expertise of Heart Team)
  • Ensure data collection on competition (at major congresses and during sites visits, literature)
  • Develop and update training material
  • Responsible to update the training procedures in collaboration with QA
  • Collect sites information of safety events when needed
  • Coordination/Participation to preclinical activities
  • Technical support during the clinical study (including transport and, Epygon TMV device preparation and crimping, data management).
  • Contribution to the definition and implementation of scientific tools to simulate and/or characterize product use and function for current and new product development and user training platforms.
  • Contribution on preparation of technical files for submission to EC/CA, for CE marking and FDA dossier approvals.
MANAGER

CMO & VP Clin Affairs

TEAM MANAGEMENT

Hierarchical and transversal people & team management

SKILL REQUIREMENTS

Technical or Specific skills and Knowledges

  • Master’s degree in biomedical/clinical related field.
  • Knowledge of ISO 13485, 5840 and MDR and other related standard regulations for class 3 medical devices.
  • Imaging software for pre-operative sizing and planning (3Mensio Structural Heart).
  • Previous experience as clinical product specialist in cardiovascular.
  • Fluent knowledge of both Italian and English languages.

Behavior skills

  • Team working in multidisciplinary research groups.
  • Planning and organizational skills.
  • Ability to communicate effectively in both technical and non-technical terms.
  • Problem Solving/Decision Making: ability to react quickly and effectively to possible challenging situations.
  • High level of autonomy and self-starting attitude.
CANDIDATE
To apply for this vacancy, please send your application to jobopportunities@affluentmedical.com