The Senior Regulatory Affairs Specialist is responsible for USand international medical device premarket and post market activities forassigned products. Products includesoftware driven electrical medical devices and standalone software (US Class I,II; EU Class I, Im, IIa). Regulatory responsibilities include, but are notlimited to, local and multi-site Product Development Teams, regulatorystrategy, applicable standards, guidances and regulations/directives,CE-Marking, Essential Requirements Checklists, Technical Files, Rest of Worldregistration, marketing collateral, labeling, regulatory intelligence, criticalanalysis and process and record maintenance.
· Serve as regulatory lead for local andmulti-site Product Development Teams for software driven electromedicaldevices, as directed. Responsibilities include: develop regulatory strategiesthat optimize US, EU and Rest of World product registration; prepare andmaintain Regulatory Strategy Plans; determine device classifications; identifyapplicable standards, guidances, and regulations/directives; participate inrisk management; approve Document Change Orders and Engineering Change Orders.
· Serve as regulatory lead for European CE-Markingrequirements and strategies for assigned Dublin CA site Product DevelopmentTeams. Responsibilities include: obtain and maintain CE-Marking for assignedproducts; prepare and maintain associated Technical Files and EssentialRequirements Checklists; lead Notified Body review and approval of TechnicalFiles; device classification; collaboration with Management Representative, ECRepresentative, and ZEISS Affiliates.
· Serve as regulatory lead for internationalregistration requirements and strategies for assigned Dublin CA site ProductDevelopment Teams. Responsibilities include: Obtain and maintain registration of assigned products in rest of worldmarkets, including Australia, Brazil, Canada, China, Mexico, Japan, Russia, SouthKorea and Taiwan, in collaboration with ZEISS Affiliates and Distributors.
· Serve asregulatory lead for US registration requirements and strategies, in collaborationwith RA US Submission colleagues, for assigned Dublin CA site ProductDevelopment Teams. Responsibilitiesinclude: device classification andproduct codes; 510(k) file/no file determinations; 510(k) documentation; asneeded, 510(k) preparation.
· Serve as regulatory lead for local SustainingProduct Teams, as assigned. Responsibilities include: assessthe impact of product changes on US, EU and Rest of World registrations.
· Serve as regulatory lead for marketingcollateral guidance, review and approval for assigned products taking intoaccount cleared/approved product claims.
· Serve as regulatory lead for labeling (manuals,instructions for use, labels, etc.) guidance, review and approval for assignedproducts taking into account regulations, standards and cleared/approvedproduct claims.
· Perform regulatory searches and notify theorganization of changes in US, EU and Rest of World laws, regulations,directives, guidances, standards, etc. that impact ZEISS.
· Maintain and work to Company SOPs. Ensure that procedures are adequate forconducting regulated clinical trials.
· A minimum of five (5) years of experience in medicaldevice Regulatory Affairs with a strong preference for software drivenelectrical medical device experience.
· A Bachelor’s degree in an appropriate disciplineor equivalent. Work experience may beconsidered in lieu of Bachelor’s degree.
· Proficient in MS Office 2016 (Word, Excel,PowerPoint), MS Windows OS (10) and the internet. .
· Strong writing, communication (written andoral), analysis, negotiation, time management and project management skills.
· Industry recognized certification (RAPS RAC)preferred.
Job Type: Full-time