Mustafa Sherif

Angestellt, Regulatory Affairs Manager, KARL STORZ SE & Co. KG
Tuttlingen, Germany

Fähigkeiten und Kenntnisse

Python
IMDRF
Clinical Evaluation Plan
Data visualisation
Clinical Evaluation Report
Literature search protocol
PMCF
IEC 62366
PSUR
Post Market surveillance
FDA 21 CFR 820
EU MDR
ISO 14971
Team work
Communication skills
Flexibility
Reliability
Commitment
FDA
ICD10
Medical technology
Medical device
Regulatory Affairs
Clinical affairs
Quality affairs
Software as a medical device
SAP
Atlassian Jira

Werdegang

Berufserfahrung von Mustafa Sherif

  • Current 2 years and 8 months, since Oct 2023

    Regulatory Affairs Manager

    KARL STORZ SE & Co. KG
  • 7 months, Jan 2023 - Jul 2023

    Regulatory affairs working student + Master thesis project

    Carl Zeiss Vision GmbH, Aalen

    Evaluate and compare country medical device regulations regarding PMS incl. their relevance for the department's software products and prototypes. Define relevant tracking parameters for active post-market surveillance for web and native applications. Create a visualization dashboard for a prototype for analyzing the collected data. Monitor the compliance radar of the department, select and summarize relevant content and present it in the radar discussions.

  • 6 months, Aug 2022 - Jan 2023

    Regulatory and Clinical affairs Working student

    Carl Zeiss Meditech AG

    Worked as part of the clinical affairs team for medical technology projects (EQ workplace, Callisto eye), with a focus on software as a medical device (SAMD). Contributed to developing clinical evaluation plans, literature search protocols, and clinical evaluations in compliance with MEDDEV 2.7/1 regulations. Collaborated cross-functionally with teams, including , regulatory affairs, and quality assurance to ensure timely completion of clinical activities and regulatory compliance.

  • 2 years, Sep 2019 - Aug 2021

    Hospital Pharmacist

    Agial Gynacology hospital

    Provide both asynchronous and synchronous consultations to patients seeking fertility treatments. Supply required medications related to IVF and ICSI surgeries. Collaborate closely with healthcare providers to ensure optimal patient outcomes. Provide emotional support.

  • 5 months, Apr 2019 - Aug 2019

    Hospital Pharmacist

    Alexandria main university hospitals

  • 2 years and 5 months, Nov 2016 - Mar 2019

    Hospital Pharmacist

    Egyptian Armed Forces

Ausbildung von Mustafa Sherif

  • 1 year and 10 months, Oct 2021 - Jul 2023

    Master of Digital health

    Technische Hochschule Deggendorf

  • 4 years and 11 months, Sep 2011 - Jul 2016

    Bachelor of Clinical Pharmacy

    Alexandria University

Sprachen

  • Arabic

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

  • German

    B1-B2 (Gute Kenntnisse)

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