{"id":2996375,"url":"https://alion.io/job/sofmedica-quality-regulatory-specialist-2","title":"Quality & Regulatory Specialist","company":{"id":9078,"name":"Sofmedica","domain":"sofmedica.com","url":"https://alion.io/company/sofmedica","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":{"grade":"A","score":87,"open_postings":3,"ghost_share":0,"stale_share":0.333,"repost_share":0,"time_to_fill_p50_days":71,"computed_at":"2026-10-26T05:57:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cairo, Egypt"],"countries":["EG"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":13500,"max_usd":35000,"period":"year","method":null,"sample_n":1456},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false}],"status":"closed","first_seen_at":"2026-08-03T00:00:00Z","employer_posted_date":"2026-08-03","last_verified_at":"2026-10-26T10:32:36Z","board_verified":false,"closed_at":"2026-10-26T10:32:36Z","days_open":84,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":84},"description":"At SOFMEDICA, we believe that innovation only matters when it reaches the people who need it most.\nEvery product we register, every process we improve, and every quality standard we uphold helps healthcare professionals deliver better care and gives patients access to life-changing medical technologies.\nWe're more than a medical technology company - we are a tribe of passionate people driven by one purpose: changing lives through innovation.\nAs part of the SOFMEDICA Group, a leading education-driven healthcare organization operating across Europe since 1994, we work alongside world-leading MedTech partners to bring cutting-edge medical technologies closer to healthcare professionals and patients.\nNow, as we continue expanding into Egypt, we're looking for a passionate and detail-oriented Quality & Regulatory Specialist to help build a strong, compliant, and trusted foundation for our business from day one.\nIf you're someone who believes quality is more than compliance and sees it as a commitment to patient safety and healthcare excellencem, we'd love to meet you.\nAs our Quality & Regulatory Specialist, you'll play a vital role in ensuring that every product we bring to the Egyptian market meets the highest standards of quality, safety, and regulatory compliance.\nYou'll help enable the introduction of innovative medical technologies while building processes that healthcare professionals can trust and patients can rely on.\nYour work will directly contribute to improving healthcare outcomes across Egypt.\nWhat You'll Be Doing\nManage product registrations, renewals, variations, and regulatory maintenance activities in Egypt.\nPrepare, review, submit, and maintain regulatory dossiers and technical documentation.\nMonitor changes in Egyptian regulatory requirements and evaluate their impact on company products and operations.\nBuild and maintain strong relationships with regulatory authorities, certification bodies, and other external stakeholders.\nEnsure product registrations, certificates, declarations, approvals, and technical documentation remain accurate, current, and audit-ready.\nDrive Quality Excellence\nMaintain and continuously improve SofMedica's Quality Management System (QMS) in accordance with applicable standards and local regulations.\nEnsure quality procedures, work instructions, records, and documentation are effectively implemented and maintained.\nSupport complaint handling, CAPA activities, supplier qualification, risk management, and continuous improvement initiatives.\nPrepare the organization for internal and external audits while ensuring ongoing compliance.\nCollaborate Across the Business\nProvide expert regulatory and quality guidance to support strategic business decisions.\nRequirements\nBachelor's degree in Pharmacy, Life Sciences, Engineering, Quality Management, Regulatory Affairs, or a related field\nExperience with Egyptian medical device regulations and registration processes\nExperience communicating directly with regulatory authorities or certification bodies\nGood understanding of Quality Management Systems\nExperience with documentation control, CAPA, audits, supplier qualification, and complaint handling\nStrong organizational skills and exceptional attention to detail\nHigh level of integrity, accountability, and professionalism\nExcellent communication and stakeholder management skills\nPassion for continuous improvement and process optimization\nFluency in Arabic and English\nBenefits\nBy joining SoFmedica, you'll enjoy the opportunity to:\nBe part of the launch and growth of SofMedica Egypt.\nWork with world-leading medical technologies that transform patient care.\nCollaborate with experienced international teams across Europe and the region.\nAccess continuous learning and professional development opportunities.\nGrow your career within a fast-growing, purpose-driven healthcare organization.\nBe part of a collaborative culture built on trust, innovation, agility, and continuous improvement.\nThis is more than your next career move, it is an opportunity to help shape the future of healthcare in Egypt.\nIf you are passionate about quality, inspired by innovation, and ready to make a meaningful impact from the very beginning, we'd love to welcome you to the SOFMEDICA 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