The Principal Regulatory Affairs Specialist works as an independent contributor and is responsible for supporting the development and implementation of the overall objectives and long-range regulatory strategies that impact the introduction of new products, the market status of existing products and the development and maintenance of systems and processes that assure compliance with regulatory requirements.
In this role, the successful candidate will collect and coordinate information to prepare regulatory documentation packages for review and submission to regulatory agencies or to our commercial partners.
The Senior Regulatory Affairs Specialist has primary responsibility for providing regulatory guidance to new product development teams, preparing regulatory filings, reviewing promotional materials, reviewing design changes, and for supporting health hazard assessments.
As the incumbent of this Quality & Regulatory (Q&R) role, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.