The Senior Regulatory Affairs Specialist is responsible for US medical device premarket submissions and post market activities for assigned products. Products include software driven electrical medical devices and standalone software (US Class I, II;). Regulatory responsibilities include, but are not limited to, 510(k) development and submission to FDA, provide local and multi-site Product Development Team support, determine U.S.regulatory strategy, including IDE and support Clinical Affairs, evaluate applicable FDA consensus standards, famialiarity with FDA guidances and current regulations.Additional responsibilities include review and approval of marketing collateral, labeling, Establishment Registration and Device Listing;; Laser Product reporting. This position will also require experience in regulatory research, critical analysis and process and record maintenance.
Serves as regulatory member for local and multi-site Product Development Teams for software driven electromedical devices. Responsibilities include: develop regulatory strategies that optimize US product registration;; determine device classifications; identify applicable standards, guidances, and regulations/directives; participate in risk management; approve Document Change Orders and Engineering Change Orders.
Serves as regulatory resource for US registration requirements and strategies, in partnership with RA US Submission colleagues for assigned Dublin CA site and OUS SSC Product Development Teams, which include device classification and product codes; 510(k) submissions and no file determinations.
Serves as regulatory resource for foreign (OUS) Product Development Teams when the product will be distributed in the US via the Dublin CA site,including device classification and product codes; review of 510(k) submissions or no file determinations; Device Listing; applicable US standards, guidance, and regulations.
Regulatory member for local Sustaining Product Teams, as assigned. Responsibilities include: assess the impact of product changes on US registrations.
Provide regulatory marketing collateral guidance, review and approval for assigned products taking into account cleared/approved product claims.
Provide regulatory labeling (User manuals, instructions for use, labels, etc.) guidance, review and approval for assigned products taking into account regulations, standards and cleared/approved product claims.
Perform regulatory intelligence and notify the organization of changes in US laws, regulations, directives, guidances, standards, etc. that impact ZEISS.
Perform post market activities (e.g., Laser Product reporting, Establishment Registration and Device Listing), as assigned.
Ensure that procedures are adequate for conducting regulated clinical trials under IDE.
Perform others duties, as assigned.