Regulatory Affairs Specialist
About this role
The Regulatory Affairs Specialist II supports global regulatory activities throughout the product lifecycle for medical devices, in vitro diagnostics (IVDs), and life science products. The role develops and executes regulatory strategies, prepares and maintains regulatory submissions and technical documentation, manages global product registrations, and supports ongoing compliance with applicable requirements.
The Specialist II serves as a regulatory partner to cross-functional teams by providing guidance for product development, design and manufacturing changes, labeling, market expansion, and compliance initiatives. The role also supports interactions with regulatory authorities, notified bodies, international representatives, and external partners.
Originally posted on Himalayas