Regulatory Affairs Engineer (Healthcare & Medical Software)Location: Remote (Nigeria / Global)Company: Amylase Inc.About AmylaseAmylase Inc. is engineering the future of medicine. We are building a 10 - pillar intelligent ecosystem that connects clinicians, patients, and hospitals, and next - generation medical technologies into one seamless platform. Our flagship product is an intelligent clinical copilot that unifies electronic records, AI - powered decision support, workflow automation, and system - wide coordination. As we expand into robotics, diagnostics, AR/VR, and advanced analytics, global regulatory compliance becomes the backbone of our innovation. That’s why this role matters. You will help shape the regulatory architecture that governs the entire Amylase ecosystem for the next decade.Role OverviewWe’re seeking a Regulatory Affairs Engineer to lead the regulatory, compliance, and safety strategy across all Amylase products, from clinical software to AI - driven medical intelligence and emerging hardware.You’ll define how Amylase meets HIPAA, GDPR, FDA, MDCG, ISO, and other global medical standards. You won’t just ensure compliance; you’ll design the systems, documentation, and processes that allow Amylase to scale safely, ethically, and globally. This is a foundational role for someone who wants to sit at the intersection of healthcare, technology, law, and product engineering.What You’ll Do Regulatory Strategy & ComplianceLead the regulatory roadmap for medical software (SaMD), AI systems, and future hardware.Interpret and apply global standards: HIPAA, GDPR, FDA 510(k)/SaMD guidance, EU MDR, ISO 13485, ISO 14971, ISO 62304.Establish the compliance framework that powers all Amylase product lines.Develop regulatory pathways for new productsDocumentation & Quality SystemsCreate and maintain Technical Documentation, Safety Files, and Design History Files.Develop and enforce quality management processes for engineering teams.Work with Quality Engineers to maintain ISO 13485–aligned QMS across Amylase.Lead internal audits, risk assessments, and safety reviews.Clinical Safety & AI GovernanceEvaluate safety and risk for AI/ML models used in clinical decision support.Ensure adherence to global AI health guidelines (FDA Action Plan, EU AI Act).Implement processes for algorithm validation, monitoring, and fairness.Collaborate with clinicians and the Data Science team to verify model performance in real - world environments.Cross - functional LeadershipWork closely with engineering, product, data science, legal, and leadership teams.Support go - to - market teams with regulatory approvals in targeted regions.Serve as the internal authority on compliance and medical safety.QualificationsRequiredBSc/MSc in Biomedical Engineering, Regulatory Affairs, Medical Informatics, or related field.3+ years working with regulatory systems in healthcare tech or medical devices.Solid understanding of healthcare privacy, quality systems, and clinical safety standards.Experience working with HIPAA, GDPR, or ISO frameworks.Strong documentation, communication, and cross - functional collaboration skills.PreferredExperience with Software as a Medical Device (SaMD).Experience with EMRs/EHRs, clinical tools, or digital health platforms.Understanding of regulatory pathways in multiple regions (US, EU, UK, Africa).Familiarity with AI/ML safety standards and clinical validation processes.What We Offer Competitive salary and an innovation - driven culture.The opportunity to architect the regulatory framework for a multi - product ecosystem.A mission - driven, remote - first culture with global reach.A chance to work on groundbreaking healthcare innovations that directly impact clinical care, patient safety, and system reliability.