Jobs in life sciences

Performance evaluation studies expert

Ref. 217 PESE
Function: Search, select and qualify suitable evaluation centers, draft evaluation protocols, monitor the study, data evaluation and analysis, write the reports
Location: The site of employment is Geel but working remotely can be considered.

The company:

The company is a fast-growing consulting company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Their objective is to provide manufacturers with practical solutions in the area of regulatory affairs and quality assurance. We help with the implementation of quality systems, technical documentation and the organization of performance evaluations (clinical studies). They are also authorized representatives for non-EU manufacturers and offer a unique solution for e-labeling, currently used by multi-billion dollar medical device and IVD companies. 
From their offices in Geel, Eindhoven, Turin and other international locations the company serves more than 250 customers worldwide. 

Job description:

This is what you will be doing

Due to continuing strategic growth, the company will be looking to expand our Performance Evaluation Studies Departmentover the coming months. 

For the role as Performance Evaluation Studies Expert is experience with IVD assay development or validation an advantage. Understanding analytical and clinical performance, including Performance Evaluation Studies, of an IVD assay is a must. 

Within the Performance Evaluation Studies department, we design, organize, monitor and document clinical and analytical performance studies for IVD manufacturers in order to support their technical documentation and to ensure the approval by the Notified Bodies. These studies are done in collaboration with European laboratories and blood banks with international recognition and, high standard private labs.

Our tasks include searching, selection and qualification of suitable evaluation centers, drafting evaluation protocols, monitoring the study, data evaluation and analysis and, writing of the evaluation reports.

The role includes, but is not limited to:

  • Searching and selection of potential collaborating evaluation sites
  • Site qualifications
  • Assist in the setup of Performance Evaluation Studies
  • Organize performance evaluations and coordinate activities of sponsor, investigator and other related parties
  • Establish study protocols (analytical and/or clinical)
  • Perform data analysis & write study reports

Offer

  • A dynamic working environment in a fast-growing company with an international reputation.
  • A remuneration package and function content proportionate to your experience.
  • The opportunity to use and develop your skills in a world class team of specialists.
  • The site of employment is Geel but working remotely can be considered.

Requested competences and skills:

This is what you will bring

  • You have a scientific degree (MSc or PhD) in (medical) biology, biomedical technology or similar.
  • Minimal 5 years working experience in the field of IVD medical devices through positions in industry, consultancy or regulatory agencies (Notified Bodies, FDA), in either manufacturing, R&D, quality or regulatory roles.
  • Knowledge of IVD Medical Device Regulations (CE, FDA, etc.) and/or quality assurance.
  • Pragmatic, enjoying a mix of activities in technology, business processes, regulatory affairs, clinical affairs, device compliance or IVD.
  • Communicative and service oriented, supporting a wide variety of clients from small start-ups to large multi-nationals, able to adapt to different company cultures and situations.
  • Strong organizational skills, detailed oriented to deal with various projects at the same time.
  • Fluent in English.
  • A good knowledge of excel.
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