Regulatory Affairs Manager

The Regulatory Affairs Manager will set and implement an effective EU Regulatory Strategy, including innovative solutions for regulatory approval. This role involves overseeing the project management of regulatory projects, integrating with global RA, R&D, and other key functional groups. Responsibilities include maintaining strong communication with global RA teams, Clinical Affairs, and R&D groups, as well as supporting external auditors like FDA and ISO assessors. The manager will provide leadership on Notified Body strategy and product registration planning, define regulatory strategies for product approvals in the EU and other regions, and create and maintain regulatory strategies for new development projects. Additionally, the role requires supporting RA compliance with site EHS policy, maintaining the effectiveness of the Quality System in accordance with Abbott Corporate requirements and applicable regulations, and ensuring products meet quality and regulatory standards for registration and compliance with QS and ISO regulations.