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Medical Affairs Specialist (Pathology)

Agilent

Piemonte

In loco

EUR 30.000 - 50.000

Tempo pieno

13 giorni fa

Descrizione del lavoro

A leading medical technology company in Italy seeks a motivated professional to join their Medical Affairs team. The role involves driving External Quality Assessment and ensuring compliance with the EU In Vitro Diagnostic Regulation. The ideal candidate will have a strong background in pathology and diagnostics, with at least 4 years of relevant experience. Benefits include a Stock Purchase Plan and a commitment to work-life balance.

Servizi

Stock Purchase Plan
Life Insurance
Pension
Healthcare
Employee Assistance Program
Holiday

Competenze

  • 4+ years of experience in diagnostics or pharmaceutical industry.
  • Knowledge of External Quality Assessment (EQA) processes.
  • Solid understanding of the EU In Vitro Diagnostic Regulation (IVDR).

Mansioni

  • Monitor and analyze EQA results and support quality improvements.
  • Resolve performance issues collaborating with cross-functional teams.
  • Ensure compliance with the EU In Vitro Diagnostic Regulation.

Conoscenze

Pathology laboratory practices
Analytical skills
Problem-solving skills
Cross-functional collaboration
English proficiency

Formazione

Bachelor’s or Master’s degree in Life Sciences
Descrizione del lavoro
Overview

Overview - We are looking for a motivated professional to join Agilent’s Medical Affairs team, where you will drive External Quality Assessment (EQA) and EU compliance with the In Vitro Diagnostic Regulation (IVDR). You will leverage pathology and diagnostic technology expertise to support cancer diagnosis projects, develop and review regulatory documentation, and collaborate with colleagues across teams to advance science and health outcomes.

Responsibilities
  • Monitor and analyze External Quality Assessment (EQA) results; track Agilent’s performance, identify trends, and support continuous quality improvements for testing segments in anatomic pathology and/or genomics.
  • Resolve performance issues by collaborating with cross-functional teams to investigate and fix assay challenges highlighted through EQA results or published scientific research.
  • Ensure compliance with the EU In Vitro Diagnostic Regulation (IVDR); assist clinical and regulatory teams in developing and maintaining documentation related to clinical performance.
  • Provide scientific insights by reviewing and assessing scientific literature to generate strong clinical evidence, guide biomarker strategy, and support regulatory documentation.
  • Collaborate across departments with Regulatory Affairs, R&D, Quality, and Marketing to align on compliance, communications, and scientific strategies.
Qualifications
  • Strong background in pathology laboratory practices, guidelines, and governance.
  • Education – Bachelor’s or Master’s degree (or equivalent) in Life Sciences, Biomedical Sciences, Pharmacy, or a related field.
  • Experience – At least 4+ years of relevant experience in diagnostics, life sciences, or pharmaceutical industry.
  • EQA expertise – Knowledge of External Quality Assessment (EQA) processes and standards, with experience interpreting results and applying them to improve diagnostic product quality.
  • Regulatory knowledge – Solid understanding of the EU In Vitro Diagnostic Regulation (IVDR, EU 2017/746), especially in clinical evidence and performance evaluation.
  • Scientific and analytical skills – Ability to evaluate clinical data, validate biomarkers, and apply evidence-based insights to projects.
  • Collaboration and communication – Proven success working in cross-functional teams and proficiency in written and spoken English.
  • On a personal level, strong problem-solving and analytical skills; eagerness to learn about Medical Affairs capabilities such as study design, evidence generation, and medical writing; good interpersonal and customer-facing communication; able to work both in a team and autonomously.
We offer
  • Stock Purchase Plan, Life Insurance, Pension, Healthcare, Employee Assistance Program, Holiday, and Company activities (benefits vary by country).
  • Opportunity to grow within a world-class company and develop your skills.
  • A collaborative, growth-oriented environment focused on integrity, information, and trust.
  • A commitment to work–life balance.
Additional Details

This job has a full-time weekly schedule and includes the option to work remotely. Our pay ranges are determined by role, level, and location; within the range, pay is influenced by work location and factors such as job-related skills, experience, and education or training. During the hiring process, a recruiter can share the specific pay range for a preferred location. Pay and benefit information by country are available from Agilent Technologies Inc., an equal opportunity employer. Qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected categories under applicable laws.

Travel Required: 35% of the time

Shift: No End Date

Job Function: Medical / Clinical

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