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Job

Clinical Evaluation Manager

  • Location

    Austria

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Leah James

  • Contact email:

    l.james@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    4 months ago

  • Expiry date:

    2021-04-08

  • Startdate:

    ASAP

Hamlyn Williams has partnered with a leading IVD company that is looking for a Clinical Evaluation Manager. 

The role will involve:

  • Managing the performance evaluation of IVD products according to European Regulations

  • The Creation and maintainance of PEP

  • Assessment of literature, document Scientific validity

  • Management of clinical performance evaluation and trials

  • Coordination of Post-market performance follow-up PMPF (planning, design, analysis, documentation)

  • You will also collaborate with external stakeholders who are involved in the performance evaluation

  • You will also work with cross-functional teams such as Regulatory affairs and Quality Management

As a Clinical Evaluation Manager you will need:

  • Experience within the IVD space 
  • Knowledge of International Regulations, e.g. FDA.
  • Prior experience in Clinical genetic laboratory experience
  • German speaking is desireable but not essential 

I am a Quality Assurance and Regulatory Affairs market specialist working with a large variety of clients across the Medical Device industries. If this role is of interest to you, or if you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Leah at +44 020 3545 1118 or at l.james@hamlynwilliams.com