Retinai

Customer Support

• Manage site relationships for awarded projects
• Review EHR records as it pertains to sponsor protocols and eligibility criteria.
• manage deliverable to sites, tailoring as needed and as contractually agreed to ensure positive relationships and outcomes for both sites and sponsors.
• Serve as an ophthalmology SME for collaboration and adjudication on ophthalmic or medical criteria with our research and data science team, for both awarded and no awarded work.
• Attend key conferences to help build and maintain relationships with sites and coordinators, facilitating confidence in our services to them.
• Serve as a US POC for our US sites as related to Candidate Identification projects.

Clinical Site Support Specialist

Compliance

• - Prepare and manage FDA submissions including 510(k), DeNovo, Pre-Submission, and Breakthrough Designation
• - Ensure completeness and compliance of all regulatory documentation
• - Coordinate cross-functional inputs for submissions (clinical, risk, usability, technical documentation)
• - Support development of US reimbursement strategy (CPT codes, payer engagement)
• - Ensure compliance with FDA, SOC2, and future MDSAP requirements
• - Support SOC2 certification processes and data privacy/security compliance
• - Support MDR compliance and technical documentation
• - Ensure alignment with ISO 13485 and ISO 14971 requirements
• - Contribute to global regulatory strategy and future certifications (e.g. MDSAP Canada)
• - Maintain and improve QMS processes related to regulatory compliance
• - Review promotional and training materials for regulatory compliance
• - Support design control, risk management, and documentation updates
• - Support internal, external, and notified body audits
• - Perform risk assessments and usability evaluations
• - Support supplier/distributor evaluation and compliance processes
• - Work with clinical teams on retrospective and prospective studies
• - Collaborate with R&D, product, and legal teams on regulatory requirements
• - Support regulatory input in product development and change management
• - Improve regulatory and quality processes
• - Support integration of compliance into development lifecycle
• - Monitor regulatory landscape (FDA, MDR, global)

Clinical Site Support Specialist

Regulatory Specialist – FDA, Global Compliance