{"id":1141746,"url":"https://alion.io/job/sofmedica-quality-regulatory-specialist","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":67,"computed_at":"2026-10-30T05:48:23Z"}},"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":["Sofia, Bulgaria"],"countries":["BG"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":35000,"max_usd":91000,"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":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-09-23T12:26:48Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-10-30T08:23:32Z","board_verified":true,"closed_at":null,"days_open":36,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":36},"description":"SOFMEDICA is a leading regional multinational company that distributes innovative medical equipment harnessing the power of precision to improve healthcare outcomes. We are deeply committed to bridging the gap between cutting-edge medical technology and patients in Central and Southeastern Europe.\nWe are looking for a Quality and Regulatory Specialist to join our team and contribute to the quality and compliance of our medical devices.\nResponsibilities:\nManage and maintain the company’s Quality Management Systems (QMS) in accordance with ISO 9001, ISO 13485, ISO 14001, and other relevant standards.\nOversee the handling of complaints and non-conformities, ensuring timely investigation, documentation, and implementation of corrective and preventive actions.\nManage and control certificates, technical documentation, and quality records to ensure compliance and traceability.\nSupervise supplier qualification, evaluation, and contract management, maintaining strong relationships and ensuring compliance with quality and regulatory requirements.\nCoordinate and maintain effective communication with competent authorities and regulatory bodies.\nParticipate in internal and external audits, supporting preparation, execution, and follow-up of audit activities.\nRequirements\nUniversity graduate\nExperience in a Quality Assurance / Regulatory Specialist role, preferably within a regulated industry (e.g., medical devices, pharmaceuticals, manufacturing, or environmental management).\nProven experience in maintaining and improving ISO management systems\nStrong understanding of quality management principles, risk management, and continuous improvement methodologies.\nDynamic and fast learner\nCapacity to communicate effectively and the ability to work in a team\nResponsible for own work, well-organized, with attention to details, familiar to work according to the procedures\nFlexible to work in dynamic environment\nFluent in Bulgarian and English\nBenefits\nBe part of a mission-driven team dedicated to improving healthcare.\nOpportunity for professional growth and continuous learning.\nA supportive and innovative work environment.\nCompetitive salary, bonuses, and comprehensive benefits.\nOpportunities for professional development and career advancement within SOFMEDICA Group.\nIf you are a committed professional who believes in integrity and wants to make a dent in the healthcare universe in our region, join us and find your tribe!","description_format":"text","description_chars":2441,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"Bulgarian","level":"Advanced (C1)","optional":false},{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":["Continuous learning","Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Medical Equipment 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