Posted in Compliance 29 days ago.
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Type: Full Time
Location: Dublin, California
SENIOR REGULATORY AFFAIRS SPECIALIST
DUBLIN, CA, USA
Step out of your comfort zone, excel and redefine the limits of what is possible. That s just what our employees are doing every single day in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.
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.
WE ARE LOOKING FOR PEOPLE WHO ARE KEEN TO TRY SOMETHING NEW:
* Serve as regulatory lead for local and multi-site Product Development Teams for software driven electromedical devices, as directed. Responsibilities include: develop regulatory strategies that optimize US, EU and Rest of World product registration; prepare and maintain Regulatory Strategy Plans; determine device classifications; identify applicable standards, guidances, and regulations/directives; participate in risk management; approve Document Change Orders and Engineering Change Orders.
* 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.
* A minimum of five (5) years of experience in medical device Regulatory Affairs with a strong preference for software driven electrical medical device experience.
* 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. In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.
JOIN US TODAY. INSPIRE PEOPLE TOMORROW.
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We are an EEO/AA/Veterans/Disabled employer.