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Job Details

Sr Regulatory Affairs Specialist

Location
Irvine, CA

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Medical Device company is seeking a Regulatory Affairs Specialist to join their team!

rnrn

Responsibilities

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  • Prepare FDA submissions (i.e. 510(k), Pre-Sub, IDE, PMA) including writing the text, analyzing relevant documents (e.g. test reports, protocols, labeling, design requirements, manuals), and preparing documentation that will accompany the submission
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  • Support international and domestic filings/registrations, including updating technical files and design dossiers;
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  • Provide proactive knowledge and expertise as a representative of Regulatory Affairs on project teams;
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  • Demonstrate technical and product-related industry knowledge and understanding of a product’s distinguishing features in the market;
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  • Analyze advertising, labeling and public communications for regulatory compliance;
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  • Ensure compliance with design control regulations during product development and delivery activities;
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  • Report any significant regulatory issues related to a product’s release;
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  • May represent RA department in project meetings and provide regulatory guidance;
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  • Support Quality teams with special projects.
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Minimum Qualifications

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  • BS in Sciences or Engineering
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  • 510(k) Submission, Design Dossiers, and Technical Files.
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  • 5 years of experience
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rn,datePosted:2018-07-12 10:40:00 00:00,validThrough:2019-07-12 22:59:00 00:00,employmentType:FULL_TIME,hiringOrganization:{name:Apex Life Sciences,@id:248427,@type:organization},jobLocation:{name:92618, Irvine,address:{addressCountry:US,addressLocality:Irvine,addressRegion:California,postalCode:92618,@type:PostalAddress},@type:place},industry:Regulatory, Regulatory Affairs, Science/R&D, Biomedical Sciences,educationRequirements:Bachelors Degree,@type:JobPosting,@context:****

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