Hassan Ali Shah

· Led the preparation and submission of comprehensive tender documents for National Unified Procurement Company (NUPCO), ensuring compliance with specifications and industry standards.

· Conducted detailed requirements analysis in order to produce well-integrated and persuasive proposals that responded to requirements as stated in Request for Proposals (RFPs) from NUPCO.

· Facilitated meetings with senior level management for proposal development input and assessment of feasibility and viability of proposed solutions.

· Quality check proposals prior to final submission to ensure accuracy, consistency and unity.

· Performed post-tender evaluations to assess the success of submissions and identify areas for improvement in future bids.

· Submitted tender proposals above Saudi Riyal 100 Million per annum, receiving bid acceptance rate above 50%.

· Managing regulatory affairs within the medical device manufacturing division, keeping up to date with changes in regulation for the Saudi Food & Drug Authority (SFDA).

· Established, documented and maintained an effective Medical Device-Quality Management System (MD-QMS) according to the international ISO standard (ISO 13485:2016).

· Developed, reviewed and continuously updated Technical Files for more than 50 + medical devices according to ISO 13485, ensuring compliance with evolving regulations from various regulatory authorities.

· Prepared, finalized and submitted applications for Medical Device (MD) and In-Vitro Diagnostic Medical Device (IVD) for Marketing Approvals from Saudi Food & Drug Authority (SFDA) that consisted of multiple Low Risk Devices bundled/grouped into a single submission.

· Reviewed and updated product labelling and promotional materials for compliance with applicable regulatory requirements.

· Received approval on multiple applications for Marketing Authorizations from Saudi Food & Drug Authority.

· Management Representative for ISO standards; ISO 22000:2018 (Food Safety Management System), ISO 14001:2015 (Environmental Management System), ISO 45001:2018 (Occupational Health & Safety Management System), ISO 13485:2015 (Medical Device Quality Management System), ISO 9001:2015 (Quality Management System), ISO 27001:2022 (Information Security Management System).

· Conducting internal audits twice per year followed by providing training and awareness based on the audit outcome.

· Inspection of incoming raw materials such as cartons, wrapping rolls and various types of polypropylene (PP) and polyethylene (HDPE, LDPE, LLDPE and etc.) utilized in the manufacturing of medical usage and food grade containers through the process of injection and blow molding techniques, ensuring quality requirements are being maintained.

· Manage control of documented information and records in accordance with the ISO standards and organizational needs.

· Managing and maintaining Nonconformity, Corrective & Preventive Action and Continuous Improvement Processes.

At the industry, Job description was to Install Electrical Equipment, Preventive Maintenance, Electrical System TROUBLE SHOOTING and Administrative Support to the Management.

· Analysis, Design, presentation of sales & technical proposals of backup power systems targeted towards electrical switchgear, solar, telecom, instrumentation & automation sectors.

· Conduct & Supervise customer site visits, analyze client requirements, prepare & present cost-effective solutions.

· Conduct sales & marketing efforts focused on end users, contractors, consultants & resellers.

· Supervised installation, testing, commissioning works for projects in Saudi Arabia.

· Generated sales of core products through a network of clients/ resellers within KSA. Clientele includes: Saudi Aramco, Saudi Electric Company, Saudi Telecom Co., Sonatrach, Ministry of Defense & Aviation, and Royal Saudi Air Force amongst many others.