Patrycja Achtzehn

Head of Quality & Regulatory Compliance at Mindable Health

Patrycja Achtzehn has a diverse work experience in the regulatory affairs and quality management field. Patrycja is currently the Head of Quality & Regulatory Compliance at Mindable Health since April 2022. Previously, they worked as a Regulatory Affairs & Quality Manager at Tilda from October 2021 to March 2022, where they developed and executed the company's global regulatory strategy and oversaw compliance for medical devices. Before that, they were a Regulatory Affairs Manager at SPECTARIS from February 2019 to September 2021, providing consultancy and preparation of technical documentation for medical devices and personal protective equipment. Patrycja also gained experience as a Regulatory Affairs Manager and Clinical Studies at S&V Technologies GmbH from April 2018 to January 2019. Prior to that, they worked at AESD Research & Development GmbH as a Regulatory Affairs and Information Security Manager, handling product registration and conformity assessment procedures for medical devices. Patrycja holds a Master's degree in Immunology and completed various research projects and a master's thesis during their studies.

Patrycja Achtzehn completed their education as follows:

From 2010 to 2013, they attended Freie Universität Berlin and earned a Bachelor of Science (B.Sc.) degree in Biochemistry.

Continuing their studies at the same university, they pursued a Master of Science (M.Sc.) degree in Biochemistry from 2013 to 2016.

In terms of additional certifications, Patrycja obtained the following:

- In January 2019, they received the Manager Regulatory Affairs (TÜV) - Medical Devices certification from TÜV Süd.

- In December 2021, they obtained a Course Certificate in Software for Medical Devices and IEC 62304 from Medical Device HQ.

- In February 2022, they acquired the Expert Quality Management Medical Device International (TÜV) certification from TÜV Rheinland Group.

It should be noted that no assumptions beyond the provided information have been made regarding Patrycja Achtzehn's education history.

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Timeline

  • Head of Quality & Regulatory Compliance

    April, 2022 - present