Experience

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  Hyaltech ltd., a carl zeiss meditec company.

  Jan 2010 - Apr 2012

  Regulatory affairs officer

  I held the position of Regulatory Affairs Officer at Hyaltech Ltd., a UK biotech company that manufactures mainly sodium hyaluronate based medical devices for a range of applications including ophthalmology, orthopaedics and aesthetic dermatology. Responsibilities:- preparation and submission of documents and dossiers for new medical device and pharmaceutical (CTD) registrations, changes and renewals worldwide including EMEA, APAC and the Americas- management of the international registration process and company registration strategy for the product portfolio- design, coordination and approval of international labelling for product packaging components- preparation, review and submission of technical files and design dossiers for CE marking under MDD 93/42/EEC and preparation of submissions for product changes- responding to questions and enquiries from customers, distributors, contractors and regulatory authorities and liaising with the relevant authorities to determine import / export requirements- notified body audit preparation- document control management- regulatory Standard Operating Procedure writing and review- clinical study preparation and clinical evaluation compilation- assisting with complaints, CAPA management and vigilance and other QA functions as required Show less

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  Hyaltech ltd, a czm company

  May 2012 - Jun 2013

  Regulatory affairs consultant

  Upon moving to Dubai I worked as a self-employed Regulatory Affairs Consultant for Hyaltech Ltd. I was responsible for updating the technical files and design dossiers for the company's portfolio of class IIb and class III products as required for re-certification of the products under MDD 93/42/EEC by the relevant notified body. This involved detailed gap analysis of practices against all applicable harmonised standards to determine state of compliance and advise on changes to be implemented to meet regulatory requirements, biological safety evaluation and report compilation, clinical evaluation, and risk analysis and risk management report preparation. Show less

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  Smith+nephew

  Jul 2013 - Apr 2022

  I led the MEA (Middle East, Africa and Turkey) Commercial Quality function, managing the Quality leads in Turkey and South Africa, as well as continuing to manage the MENA-SSA (Middle East North Africa – Sub-Saharan Africa) Quality function directly and serving as the Quality Management Representative for the business. As Commercial Quality lead for the cluster I worked to provide strategic direction and align and standardise processes in the three commercial sites, in line with global project plans, in order to drive quality improvements and greater efficiencies. This has recently included implementation of the global eQMS system for management of key areas such as document control, audit management and NC & CAPA. I worked closely with key business stakeholders, including Top Management in order to align on strategy and prioritise projects. I also had the opportunity to manage key Regulatory Affairs activities for the MENA-SSA region, including development and implementation of the Control of Advertising & Promotional Material process and assessment and alignment of vigilance reporting requirements within the region. I had the opportunity to keep abreast of new/updated regional and international regulations as part of the regulatory intelligence process, including EU MDR. Show less Whilst continuing my role as a project manager and key regional support for the IRAMEA (later APAC & EM) Commercial Quality organisation, I also took on responsibility for MENAT (Middle East North Africa & Turkey) Commercial Quality in 2015. I took over responsibility for management of all Quality activities for the MENA operation including QMS implementation/improvement as per ISO 13485 requirements and Smith & Nephew global/regional standards, complaint management, execution of Quality Holds & Field Actions, management of nonconforming product process, supplier quality management (including working closely with the 3PL warehouse to optimise processes and ensure compliance to GSDP requirements), distributor management etc. I led the internal audit programme and was responsible for CAPA management. I served as a key business partner to core commercial functions such as RA and Supply Chain and worked to ensure that high levels of quality were maintained. I also provided oversight, direction and support to the Commercial Quality function in Turkey. Show less I joined Smith & Nephew as RA Associate responsible for key regulatory projects for the newly formed IRAMEA-LA (India, Russia, Asia, Middle East & Africa and Latin America) organisation for which the Dubai office was the regional HQ. I was responsible for the implementation of a product license database in order to ensure that only registered products were shipped from the manufacturing sites to the relevant IRAMEA-LA markets. This involved collection of product license data and understanding and communicating the registration requirements for each market to the project team and key stakeholders. I also managed the regulatory integration of Smith & Nephew Turkey following the acquisition of the Turkish distributor, in order to ensure that product registrations and reimbursement approvals were transferred to Smith & Nephew Turkey in a timely and compliant manner. I was also involved in other key regulatory projects such as development of an NPD process to ensure that the regulatory requirements of the IRAMEA-LA markets were considered during design of a new product/line extension, and providing guidance on the preparation and review of clinical evaluation reports for the product portfolio of the acquired Adler manufacturing site in India. I also assisted in coordination and tracking of clinical activities within IRAMEA. Show less

  • Senior Quality Manager

    Nov 2018 - Apr 2022

  • Quality Manager

    Apr 2015 - Nov 2018

  • Quality Assurance Associate

    Jan 2015 - Apr 2015

  • Regulatory Affairs Associate

    Jul 2013 - Dec 2014
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  Bausch & lomb

  Jun 2022 - now

  Quality assurance manager