{"id":3740112,"url":"https://alion.io/job/uromedtech-regulatory-affairs-specialist","title":"Regulatory Affairs Specialist","company":{"id":3802211,"name":"Uromedtech","domain":"uromedtech.com","url":"https://alion.io/company/uromedtech","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":null,"truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Singapore"],"countries":["SG"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":4500,"max":6000,"currency":"SGD","period":"month","gross":true,"usd_annual":56208},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"ISO 10993","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false},{"name":"EU MDR","optional":true},{"name":"IEC 60601","optional":true},{"name":"IEC 62304","optional":true},{"name":"IEC 62366","optional":true}],"status":"live","first_seen_at":"2026-11-04T00:00:00Z","employer_posted_date":null,"last_verified_at":"2026-11-04T00:00:00Z","board_verified":false,"closed_at":null,"days_open":11,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":11},"description":"Based at our Singapore headquarters, the Regulatory Affairs Specialist will support the development and execution of regulatory strategies for UroMedtech products across international markets.\nThe role will be responsible for preparing and coordinating medical device registration submissions, maintaining regulatory documentation, responding to authority queries, managing regulatory activities with distributors and local representatives, and supporting post-market regulatory compliance.\nThe successful candidate will play an important role in enabling UroMedtech's international expansion by ensuring that regulatory pathways are planned early, submissions are executed efficiently, and product registrations remain compliant throughout the product lifecycle.\nKey Responsibilities\nInternational Product Registration\nSupport and coordinate medical-device registrations across UroMedtech's priority international markets.\nPrepare, compile, review and maintain regulatory submission dossiers in accordance with applicable country requirements.\nCoordinate registration activities with local distributors, authorized representatives, regulatory consultants and other in-country partners.\nTrack submission status, authority queries, approvals, licence validity and renewal requirements.\nPrepare responses to regulatory authority questions and requests for additional information in collaboration with relevant internal teams.\nMaintain clear registration timelines and proactively identify potential regulatory delays or risks.\nSupport regulatory activities for new products, new indications, product modifications and market expansion.\nRegulatory Strategy & Market Access Planning\nResearch and assess regulatory pathways and classification requirements for new international markets.\nSupport development of country-specific regulatory strategies, timelines, documentation requirements and registration plans.\nIdentify regulatory dependencies that may affect product launch or commercial timelines.\nProvide regulatory input to Commercial and Management teams during market-entry planning.\nTechnical Documentation & Submission Dossiers\nPrepare and maintain regulatory technical documentation and submission dossiers in accordance with applicable requirements.\nSupport preparation and maintenance of device descriptions and intended use, product specifications, Essential Principles / General Safety and Performance Requirements, documentation relating to risk management, verification and validation, software, clinical evaluation and clinical evidence, applicable biocompatibility and electrical safety, labelling, Instructions for Use, packaging, and Post-Market Surveillance.\nEnsure regulatory documents are accurate, consistent, traceable and appropriately controlled.\nCoordinate with R&D, Engineering, Clinical and QA teams to obtain required technical evidence and supporting documentation.\nProduct Change & Lifecycle Management\nAssess regulatory implications of product, software, manufacturing, labelling and supplier changes.\nSupport regulatory change assessments and determine whether notifications, variations or new submissions are required in relevant markets.\nMaintain accurate records of country-specific approved product configurations and regulatory commitments.\nCoordinate regulatory activities related to product updates and software releases.\nSupport licence renewals and ongoing maintenance of international registrations.\nRegulatory Partner & Distributor Management\nServe as a key regulatory contact for international distributors and local regulatory representatives.\nProvide distributors with appropriate regulatory documentation and guidance for local registrations.\nReview regulatory materials prepared by distributors or external consultants for accuracy and consistency.\nEstablish clear responsibilities, timelines and follow-up actions for registration projects.\nMaintain organized records of regulatory correspondence, submissions, approvals and commitments by country.\nQuality & Post-Market Regulatory Support\nWork closely with QA to support compliance with the company's Quality Management System and applicable medical-device regulations.\nSupport regulatory reporting requirements related to complaints, adverse events, field safety corrective actions and other post-market activities when required.\nSupport regulatory inspections, audits and authority requests when required.\nEnsure regulatory commitments made during product registration are communicated internally and fulfilled.\nCross-Functional Collaboration\nCollaborate and work with Product, R&D, Clinical, Commercial, Operations and Manufacturing teams regarding regulatory requirements, documentation, submissions, and timelines.\nParticipate in cross-functional product development and product-change meetings where regulatory input is required.\nRegulatory Intelligence\nMonitor relevant regulatory developments in international medical-device markets.\nMaintain current knowledge of applicable standards, guidance documents and regulatory requirements.\nAssess emerging regulatory requirements relevant to medical robotics, software, AI-enabled medical devices and image-guided technologies.\nCommunicate significant regulatory changes and their potential business impact to relevant internal stakeholders.\nQualifications & Experience\nBachelor's degree in Biomedical Engineering, Life Sciences, Pharmacy, Medical Science, Engineering or a related discipline.\nApproximately 3–6 years of Regulatory Affairs experience within the medical-device industry.\nHands-on experience preparing or supporting medical-device registration submissions.\nWorking knowledge of medical-device technical documentation and Quality Management Systems.\nFamiliarity with ISO 13485, ISO 14971 and applicable medical-device regulatory frameworks.\nExperience coordinating regulatory submissions with internal stakeholders and external partners.\nPreferred Experience\nExperience with regulatory requirements and submissions in multiple international markets, particularly EU/CE, US/FDA and Asia-Pacific region (Singapore, ASEAN).\nExperience with Australia TGA, CE and FDA international regulatory pathways would be advantageous.\nExperience with Class II / Class III or equivalent moderate-to-high-risk medical devices.\nExperience with software-containing medical devices, medical robotics, ultrasound, imaging or AI-enabled medical technology.\nFamiliarity with IEC 60601, IEC 62304, IEC 62366 and other relevant medical-device standards.\nExperience working with international distributors, authorized representatives and regulatory consultants.\nExperience supporting product changes, software updates and lifecycle regulatory activities.\nSkills\nFDA, Regulatory Compliance, Quality Assurance, Regulatory Affairs, ISO, Regulatory Strategy, TGA, Biomedical Engineering, Medical Devices, Regulatory Support, Medical Device Regulations, Regulatory Processes, Stakeholder Management, Product Lifecycle, Regulatory Submissions","description_format":"text","description_chars":6974,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & 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