Responsible for delivery of site activation readiness, preparation of Clinical Trial Application Forms, and interaction with CA/EC for study purposes. Providing updates about submissions, maintaining project plans, and customizing Patient Information Sheets. Act as SME for collection and maintenance of site level critical path to Site Activation data points. May support the clinical team performing Pre-Study Site Visits.
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As a Senior Regulatory Affairs Engineer at Neko Health, you will assign product codes and IDs, own product registrations, maintain establishment listings and reporting, manage legal representatives, drive regulatory intelligence, support product development, and empower process owners and teams. Your role involves keeping registrations of multiple devices in multiple markets current.
Ensure our cutting-edge medical devices meet global standards and regulations as well as align with regulatory strategies from research and development to market launch and post-market. You will advise on regulatory strategy throughout the product lifecycle, influencing design, risk management, supplier selection, and device labeling. You will also prepare and submit documentation for EU MDR, FDA, and other international markets.
This leader will shape and lead value and access submission and negotiation planning, including optimal country launch sequence and ensure sustainable access in key European markets. This role will be a core member of the Europe Region leadership team, working cross-functionally to influence long-term growth and patient impact, to build a global multi-billion company serving patients suffering from rare neuro-muscular diseases.
Are you ready to take your career to the next level? Join our dynamic team at SGS and become a Senior Product Assessor - Active Devices where you will manage a small team of globally based Product Assessors and dive deep into the exciting world of Active Medical Devices. As a member of our Medical Device team you will conduct thorough technical documentation reviews and ensure compliance with EU regulations and standards.