Jan-Bart Hak Email & Phone Number

Specialties: Regulatory Affairs (Medical Device Regulation 2017/745; In vitro diagnostics 2017/746); Clinical Evaluation and Clinical Research (ISO14155-GCP); CE marking, Quality Management Systems (ISO13485;2016 A11; QSR 21CFR, part 820), Medical Device development, Device Vigilance; Project management, budget and resource management;

Listed skills include Regulatory Affairs, Clinical Trials, Cro, Clinical Research, and 14 others.

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  Director Medical Devices Europe

  Propharma

  Jan 2019 - Present - Leiden, The Netherlands

  Heading the medical device department and services in Europe, responsible for budget and resources. I'm focused on bringing products to the market in a fast and efficient manner and ensure that the can be kept there. My skills and knowledge for medical devices and combination products related to various markets include:Regulatory Affairs (Medical Device 2017/745 and In-Vitro Diagnostic Regulation 2017/746); technical documentation.Clinical Evaluation, post market surveillance, post market clinical follow up.Clinical Affairs, clinical strategy considering the various stakeholders (ISO14155-GCP); Product registration, CE Marking; FDA registrationQuality Management Systems; ISO13485;2016, QSR CFR21 Part 820Supporting device introduction strategies (Marketing and Sales)