Ahmed Algarni

Experience

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  King Fahad Medical City - KFMC

  Jul 2009 - May 2011

  Biomedical Engineer

  • Led a team in managing new orders, maintenance, and PPM for all general biomedical devices at King Fahad Medical City.• Oversaw operations for devices excluding specialized ones like Radiology and lab equipment.• Implemented efficient maintenance strategies resulting in increased device uptime and improved patient care outcomes.

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  Saudi Food & Drug Authority

  Jun 2011 - Apr 2014

  Biomedical Licensing Specialist

  During this period i learned all SFDA regulations in medical devices field and what is the processes for the following systems ( MDEL , MDMA , MDNR , Classification ).MDEL : Establishment licensing is intended to ensure that an establishment is able to: - Undertake all necessary customs procedures.- Undertake all activities required to ensure appropriate management of the medical devices it import or distribute.- Comply with the manufacturer’s requirements for the storage, handling, transport, installation and maintenance of medical devices it imports or distributes.- Involved in trace all medical device it imports or distributes through that part of supply chain with which it is directly involved............................................................MDNR : Purpose of MDNR :◊To obtain a profile of the Saudi Arabia medical devices industry.◊To establish a database of all establishments, manufacturers, agents and suppliers working in the field of medical devices, in vitro diagnostics, prescription eye glasses, contact lenses and their solutions .◊To measure the readiness of medical devices establishments in conforming to the regulatory requirements. ..............MDMA : is an electronic system aims to authorize medical devices after they comply with the Medical Devices Interim Regulation (MDIR) and in particular to the implementing rule MDS-IR6 for Medical Device Marketing Authorisation (MDMA). The system allows local manufacturers and overseas manufacturers authorized representatives to apply electronically for medical devices marketing authorization which permits relevant medical devices to be placed on the market of the Kingdom of Saudi Arabia, when satisfied that the applicant has provided all the required information for market authorization. Show less

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  Dräger

  Feb 2019 - now

  The local Compliance appointee oversees as an interface between the Corporate Compliance Office and the local organization and in addition to the Managing Director the Dräger Compliance Management System with a scope on anti-corruption, antitrust, conflicts of interests and fraud at local level. Functioning as an independent and objective body he reviews and evaluates compliance objectives within the local organization. The position ensures that appropriate measures are taken that enable management and employees to be compliant with Dräger's Principles of Business and Conduct, Compliance-related directives, external and internal regulations and procedures. Show less The Data Protection Officer (DPO) is responsible for corporate data protection pursuant to the Drager Data Protection Group Directive and corresponding standards as well as applicable state law and reports unbound by directives to the country manager, the respective management and to the Group Data Protection Officer. A Data Protection Manager (DPM) is always appointed in those Drager companies, in which no Data Protection Officer is stipulated by the respective state legislation. In such cases the Data Protection Manager has the same responsibilities for corporate data as a Data Protection Officer. Show less

  • Country Quality and RA Manager

    May 2015 - now

  • Regulatory Affairs Manager

    May 2014 - now

  • Compliance Officer

    Mar 2017 - Apr 2023

  • Data Privacy Officer

    Feb 2019 - May 2020