Regulatory affairs leadership position within NanoString Technologies. The Director, Regulatory Affairs responsible for guiding regulatory affairs department daily activities culminating in the preparation of relevant regulatory filings to FDA and global regulatory authorities, with a focus on companion diagnostics. Responsibilities include life-cycle management of pipeline products that are both marketed and in development, maintenance of needed registrations and certifications, and alignment of regulatory strategy with corporate strategy in conjunction with senior management.
The Regulatory Director has company-wide influence, responsibility and functions as an internal expert resource. The individual will be actively called upon to provide regulatory guidance to business unit leadership and project teams.