What are the responsibilities and job description for the Director – Regulatory & Clinical Affairs position at OptraSCAN?
About OptraSCAN
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 to lead global regulatory submissions, U.S. FDA interactions, and clinical affairs strategy for our digital pathology and AI-driven diagnostic products. This role will be responsible for ensuring compliance, driving clinical evidence generation, and enabling successful product approvals in the U.S. and global markets.
This is a senior leadership role ideal for candidates with strong experience in medical devices, diagnostics, digital imaging, and SaMD/AI-ML products.
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).
- 10–15 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