Senior Manager, Regulatory Affairs - Device

Works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research & Development (R&D) organizations. Represents RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. Prepares device regulatory product strategies. Prepares and manages regulatory submissions and responds to regulatory information. Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions. Develops strategies for device agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions. Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests. Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization. Develops, implements, and documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA Device.