The Senior Regulatory Affairs Specialist is responsible for US and international medical device premarket and post market activities for assigned products. Products include software driven electrical medical devices and standalone software (US Class I, II; EU Class I, Im, IIa). Regulatory responsibilities include, but are not limited to, local and multi-site Product Development Teams, regulatory strategy, applicable standards, guidances and regulations/directives, CE-Marking, Essential Requirements Checklists, Technical Files, Rest of World registration, marketing collateral, labeling, regulatory intelligence, critical analysis and process and record maintenance.
• Serve as regulatory lead for European CE-Marking requirements and strategies for assigned Dublin CA site Product Development Teams. Responsibilities include: obtain and maintain CE-Marking for assigned products; prepare and maintain associated Technical Files and Essential Requirements Checklists; lead Notified Body review and approval of Technical Files; device classification; collaboration with Management Representative, EC Representative, and ZEISS Affiliates.
• Serve as regulatory lead for international registration requirements and strategies for assigned Dublin CA site Product Development Teams. Responsibilities include: Obtain and maintain registration of assigned products in rest of world markets, including Australia, Brazil, Canada, China, Mexico, Japan, Russia, South Korea and Taiwan, in collaboration with ZEISS Affiliates and Distributors.
• Serve as regulatory lead for US registration requirements and strategies, in collaboration with RA US Submission colleagues, for assigned Dublin CA site Product Development Teams. Responsibilities include: device classification and product codes; 510(k) file/no file determinations; 510(k) documentation; as needed, 510(k) preparation.
• Serve as regulatory lead for local Sustaining Product Teams, as assigned. Responsibilities include: assess the impact of product changes on US, EU and Rest of World registrations.
• Serve as regulatory lead for marketing collateral guidance, review and approval for assigned products taking into account cleared/approved product claims.
• Serve as regulatory lead for labeling (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 searches and notify the organization 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 for conducting regulated clinical trials.
• Perform other duties, as assigned.
• A Bachelor’s degree in an appropriate discipline or equivalent. Work experience may be considered 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 and oral), analysis, negotiation, time management and project management skills.
• Industry recognized certification (RAPS RAC) preferred.
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Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.
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