Medical Affairs Clinical Specialist

Florence , Tuscany, Italy

Type: n/a

Category: Healthcare & Pharma

Requirements: English
Company: Esaote
Region: Florence , Tuscany

Who we are:

Esaote is an international Group, engaged since ever in the research, manufacturing and commercialization of technological solutions aimed at achieving highest levels of excellence and efficiency in the field of diagnostic imaging. With a solid 40-year history, we are one of the world's leading manufacturers of biomedical equipment, with a particular focus on the production of ultrasound and dedicated magnetic resonance imaging systems.

Our Mission: Complexity is simple

We strive to share our unique vision and values with the world by integrating advanced software with ultrasound and MRI devices, extracting the utmost from medical images. Our goal is to provide professionals with cutting-edge tools for making optimal decisions in patient care.

Our Vision: More in less

We envision a future where highly accurate diagnosis and treatment are accomplished using our straightforward yet powerful medical devices as the preferred choice in supporting patient care.

Our values:

Teamwork, Commitment, Integrity, Results and Customer focus.

The role:

For our Medical Affairs department, we are looking for a Medical Affairs Clinical Specialist to join our team in Florence . As a Medical Doctor, You will contribute to the entire product lifecycle by meticulously documenting, gathering, and, when required, generating clinical evidence. In this role, you will play a crucial role in establishing and maintaining a positive residual risk/clinical benefit profile for Esaote products in the market. Your contribution will be essential in effectively communicating the safety and efficacy of our products in a clinical context, thereby contributing to the overall success of our presence in the medical market.

Main Responsibilities:

• Support the definition of product requirements by providing RD and Global Marketing input specification to align Esaote's products with the latest clinical guidelines and best practices.
• Lead the Clinical Evaluation Process collecting, evaluating, and analyzing clinical data to assess the device's compliance with essential safety and performance requirements.
• Contribute to the definition and execution of the Product Validation Plan. Identify new product features or requirements that may have safety concerns and release the Clinical Evaluation Plan.
• Drive the Post Market Surveillance Process by coordinating with other corporate functions, systematically collecting and reviewing post-market information to monitor clinical performance and safety. Update the clinical evaluation and risk/benefit profile as needed, and release/update safety reports.
• Contribute and participate in Medical Device Reporting (MDR) activities led by Quality Assurance department. Evaluate, from a clinical standpoint, the severity and probability of risks related to incident or potential incident reports in the Risk Management process.
• Be the point of contact with the Key Opinion Leaders within our business sector.

Qualifications:

• Medical background: Degree in Medicine.
• Technical knowledge or prior experience with Ultrasound or Magnetic Resonance Imaging equipment will be considered as a strong plus.
• Experience in medical writing.
• Proficiency in English language. Knowledge of additional languages will be considered positively.
• Ability to travel nationally and internationally as required.
• Excellent communication and presentation skills.
• Accuracy and reliability.
• Ability to meet deadlines.
• Team-oriented mindset.

What we offer:

Open ended contract with a competitive remuneration.

Esaote is an equal opportunity employer that celebrate diversity and is committed to create an inclusive environment for all employees. We prohibit and condemn discrimination and harassment of any kind based on gender, age, religion, sexual orientation, national origin, disability, or any other status protected by laws or regulations in the locations where we operate.

All employment decisions, including recruiting and hiring, at Esaote are based on business needs, job requirements, individual qualifications, and merit.

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