Director – Regulatory

6 days ago

San Jose, United States OptraSCAN Full time

Director – Regulatory & Clinical Affairs (USA) OptraSCAN is a global leader in digital pathology and precision medicine solutions, specializing in whole-slide imaging systems, AI‑driven analytics, and cloud‑enabled telepathology platforms. With customers across the US, Europe, and Asia, OptraSCAN is transforming disease diagnostics through cutting‑edge technology and innovation. Position Overview OptraSCAN Inc. is seeking an experienced Director – Regulatory & Clinical Affairs (USA) to lead regulatory submissions, U.S. FDA interactions, and clinical affairs strategy for our digital pathology and AI‑driven diagnostic products. This senior leadership role will ensure compliance, drive clinical evidence generation, and enable successful product approvals in the U.S. and global markets. Key Responsibilities Regulatory Affairs – U.S. & Global Develop and execute regulatory strategies for digital pathology products, imaging devices, and AI/ML‑based medical software. Lead U.S. FDA submissions including 510(k), De Novo, PMA, Q‑sub meetings, responses, amendments, and technical files. Prepare regulatory documents including design dossiers, device master files, labeling, CERs, and risk management documentation. Act as primary liaison with U.S. FDA and participate in pre‑submission meetings, inspections, and audits. Oversee global regulatory preparation (EU MDR/IVDR, Canada, Australia, APAC as applicable). Clinical Affairs Develop clinical strategy for U.S. and global product validations. Oversee clinical study design, IRB submissions, site selection, investigator management, CRO coordination, enrolment tracking, and study governance. Lead data collection, clinical evaluation reports, safety assessments, and post‑market clinical follow‑ups. Ensure compliance with Good Clinical Practice (GCP), clinical regulations, and global standards. Compliance & Cross‑Functional Leadership Ensure adherence to ISO 13485, ISO 14971, IEC 62304, IEC 60601, FDA QSR (21 CFR 820), and SaMD guidelines. Provide regulatory input into product development, risk analysis, labeling, market claims, and change management. Support Quality Assurance in inspection readiness, CAPA, internal audits, and documentation. Collaborate with R&D, QA, Product Management, and Operations teams across U.S. and India. Required Qualifications Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field (Master’s preferred). 8 to 10 years of experience in U.S. medical device or diagnostics regulatory affairs and clinical affairs. Proven success with FDA regulatory pathways: 510(k), De Novo, PMA. Experience with digital pathology, imaging, scanners, diagnostics, or software‑as‑a‑medical‑device (SaMD). Strong understanding of global regulatory systems (EU MDR/IVDR, Health Canada, TGA). Demonstrated leadership in managing regulatory teams or complex cross‑functional projects. Preferred Qualifications RAC (Regulatory Affairs Certification) Experience with AI/ML‑enabled diagnostic tools Experience leading global multi‑site clinical trials Knowledge of cloud‑based digital diagnostic systems Seniority level: Director Employment type: Full‑time Job function: Legal Industries: Medical Equipment Manufacturing #J-18808-Ljbffr

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