IMMY

The Regulatory Affairs Associate is responsible for preparing IVD regulatory documents for domestic and international submissions and interacting with regulatory bodies. They also ensure product compliance, maintain technical documentation, and establish standardized regulatory protocols.

The Regulatory Affairs Specialist is responsible for preparing and maintaining U.S. FDA regulatory submissions for in vitro diagnostic products. They also ensure ongoing compliance by managing registrations, labeling, and post-market reporting requirements.

The Clinical Affairs Associate supports evidence generation by coordinating clinical studies, managing site communications, and ensuring documentation is audit-ready. They also assist with post-market surveillance activities, including literature reviews and regulatory reporting to ensure product safety and performance.