Regulatory Affairs Specialist II

Job description

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. Advancing possibilities for a brighter tomorrow Boston Scientific is seeking a highly motivated Regulatory Affairs Specialist II on a permanent basis to join our team based at our Clonmel site. Job Purpose: The Regulatory Affairs Specialist is responsible for activities which lead to and maintain regulatory approval to market devices. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and ensures continued compliance with regulatory agency approvals. Key Responsibilities: - Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation. - Review, assessment and sign-off on...