Thermo Fisher Scientific seeks a Regulatory Affairs Specialist II to ensure product compliance and market access for diagnostic solutions. The role involves managing regulatory submissions, maintaining product registrations, and supporting quality systems across integral markets while collaborating with cross-functional teams.
Responsibilities
Manage regulatory submissions and maintain product registrations across global markets
Support quality management systems and ensure ongoing compliance with regulatory standards
Prepare and review technical documentation for product development and maintenance
Execute product lifecycle management and change control processes
Handle post-market surveillance and vigilance reporting activities
Requirements




Advanced degree with no prior experience, or bachelor's degree plus 2 years regulatory affairs experience
Life sciences, chemistry, pharmacy, engineering, or related scientific field background
Knowledge of FDA, EU IVDR/MDR, and regional regulatory requirements
Understanding of ISO *****, GMP, and MDSAP quality management systems
Experience preparing and reviewing technical documentation and regulatory submissions
Fluency in English; proficiency in Microsoft Office and regulatory information systems
Strong project management, analytical, and communication skills

📌 Regulatory Affairs Specialist Ii (Xico)
🏢 Thermo Fisher Scientific
📍 Xico