RA manager, TW&HK

Lead regulatory submissions and strategy for medical devices and/or pharmaceuticals across the product lifecycle. Direct submission development of product registrations and related reports; provide strategic direction on interactions with regulatory agencies; act as regulatory liaison on project teams; contribute to regulatory strategy, risk management, and CMC activities; ensure trial designs and documentation meet regulatory requirements and support rapid/ongoing approvals; collaborate with marketing and development teams on changes to manufacturing, labeling, and regulatory interpretations; coordinate and prepare submission reports and maintain timelines.