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Regulatory Affairs Intern - Submissions

Monrovia, CA

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Regulatory Affairs Intern - Submissions
STAAR Surgical Co

Job #684940316
OVERALL JOB SUMMARY • Assist current regulatory staff with FDA and international regulatory submissions including 510(k), PMA, design dossiers, technical files, and other registrations, as needed for Class I, II and III medical devices. This may include: o Coordination of essential documents/tools for regulatory submissions (i.e. prepare the required amount of copies, labels required for cover labels and attachments, etc.). o Quality check submissions for compliance with applicable regulations. o Preparation and maintenance of annual renewals of Establishment Registrations, State Manufacturing licenses, Device Listing, and other pertinent domestic and international licensing. o Compile information necessary for periodic reports for Regulatory filings. • Review and interpret regulatory rules and ensure that they are included in company/department practices/procedures. • Review complex reports, validations, etc. for scientific merit and regulatory appropriateness. • Review/Edit communications; including memos, correspondence, SOPs and presentations. • Review/Prepare Standard Operating Procedures (SOPs). • Maintain a matrix for international country regulations for product submissions. • Assess/Index/Organize regulatory library. o Compliance to Regulatory Filings. o Verification of support related to that the intended use and claims. o Determination of regulatory submission requirements according to domestic and international regulations. • Develop/review procedures for compliance with the intent of EN ISO 13485, and 21 CFR 820. • Participate in/Support Health Authority Inspections. • Review materials prior to presentation to investigators/ or response submissions. • Perform or participate in the following activities: o Risk analysis. o Root cause analysis. • Participate on remediation teams. • Other duties as assigned. EDUCATION & TRAINING • B.A. /B.S. degree preferred. EXPERIENCE • One or two years of work experience preferred. SKILLS • Thorough understanding of FDA and international regulations. • Strong working knowledge of medical devices regulations and terminologies. • Excellent written and oral communication, and technical writing and editing skills. • Ability to write clear, understandable technical documentation. • Skilled at analyzing and summarizing data. • Proficient with Microsoft Office. • Ability to follow written and verbal directions with a high level of accuracy. • Attention to detail. • Ability to work in a team setting. STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.
Updated 06/13/2018
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