Manager, Regulatory Affairs Device-Combination Products

The Manager, Regulatory Affairs Device, works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for global regulatory submissions, including IN - Ds/ CT - As and amendments, new market applications and supplements/variations with limited management supervision. Build and maintain relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA Device on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations. Responsibilities:Prepares device regulatory product strategies with limited supervision. Prepares regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision and responds t...Regulatory Affairs, Manager, Device, Regulatory, Product Development, Operations, Technology