The Regulatory Specialist helps create, develop and maintain materials needed for regulatory compliance. Assists with company compliance activities, new product submissions, listings, and registration of medical devices. Works independently as…
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program,…
The Senior Regulatory Affairs Specialist will lead the team in preparing global regulatory documents and submissions, according to standards, for all products. This key team member will play a crucial…
Key Responsibilities Guide the development, planning, and execution of regulatory submission strategies in line with corporate and program goals and timelines through alignment of key activities Lead the preparation and…
ESSENTIAL FUNCTIONS: Identifies issues to be addressed and areas of concern where IVDR may hinder the registration and sale of Quidel products Prepares and communicates IVDR project-related documentation and budgets…
Company is developing cardiovascular devices (at various stages in the PD lifecycle) and looking for a hands on Director/Sr. Dir/VP of RA, to report to their President/COO. This person will…