Specialist, Commercial Quality & Regulatory Affairs

Prepare and manage regulatory submissions and technical documentation to obtain and maintain product approvals for IVD devices. Oversee quality management processes, including audits, CAPA, and compliance operations across local and global levels. Requires a Bachelor's degree with 2+ years of experience or 3+ years of experience in medical devices or a related industry. Must be familiar with regulatory guidelines for diagnostic products and possess strong organizational and multitasking abilities.