Medical Affairs Director

Medical Affairs Director

Stryker

Amsterdam, Netherlands

As Director (Medical Expert) in the Medical Affairs team, you will be an integral part of both the Risk Management Team and the Clinical Evaluation team for Legacy Wright medical devices. Your role in the Risk Management Team will be to:

  • provide scientifically founded expertise to support the severity and probability of occurrence of harm assessments;
  • create benefit-risk analysis for each residual risk; and
  • prepare evaluation of the overall residual risk.

This expertise will draw both from your clinical experience as a surgeon and from the thorough analysis of the relevant clinical evidence compiled in the clinical evaluation report.

In the Clinical Evaluation team, you will act as the main scientific coordinator and reviewer in the creation and update of Clinical Evaluation Reports.

As such you will be responsible for their clinical accuracy, pertinence, completeness and scientific validity, and for their alignment with the risk management files. You will work in close in collaboration with Medical writers, the clinical research team, as well as R&D and RA project partners. For each Medical Device under evaluation, your role will be to:

  • Define the overall evaluation strategy (equivalence, outcome measures, comparators) with the Medical Writers;
  • Identify the key elements in the current clinical State of the Art based on a systematically retrieved literature;
  • Support the systematic appraisal and analysis of all available clinical data according to their quality and pertinence;
  • Draw conclusion on safety and performance, as well as the acceptability of the risk-benefit profile;
  • Define, in collaboration with the clinical research team, the objectives of any Post Market Clinical Follow-up studies required.

Your Profile

  • You have a Medical Degree (MD) with a specialization in Orthopedic and Trauma surgery, with at least 5 years of clinical practice;
  • Specialist experience in shoulder arthroplasty and/or ankle arthroplasty;
  • You have conducted studies or authored peer-reviewed articles in the field of trauma or orthopedic surgery and are thus familiar with the methodologies applied in the medical sciences;
  • You are competent in the systematic review and analysis of scientific literature;
  • You possess and excellent command of written and spoken English and are trained in scientific writing;
  • You value an international working environment, working across sites and indications.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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