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Regulatory Affairs Specialist

Company: PREAT Corporation
Location: Santa Maria
Posted on: February 14, 2020

Job Description:

PREAT Corporation is a leading Medical Device Manufacturer specializing in Dental Implant Prosthetics and Attachments. This is a new position due to rapid growth.This professional will work with the existing Quality Control team and answer directly to your Quality Control Manager.We offer a very competitive salary and benefits package in Santa Maria, CA. Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy Timely compile materials for license renewals, updates and registrations Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners Review labeling and labels for compliance with regulatory requirements Review changes to existing products and SOPs to define the requirements for regulatory submissions Provide the regulatory reviews of customer complaints and define the regulatory reportability Maintain current knowledge of FDA, Health Canada, European Union, and other international regulation, guidance and standards applicable to company products Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process Complete submissions to FDA, EU regulatory entities Create and maintain product EU technical files Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws Lead on any ISO, FDA or other Quality audit Lead and Manage all direct reports, including coaching sessions, progressive disciplinary actions, performance reviews Active member of Preat Leadership Team, contributions to overall strategic planning and execution Department Budget Management Improve existing processes and develops new processes to improve efficiencies Skills and Qualifications: -Product Knowledge -Quality Focus -Teamwork -Coordination -Organization -Planning -Time Management -Documentation Skills - Data Entry Skills Please also take our Cultural Index survey; no candidate will be considered without completing this short 5 minute survey. Respectfully, Chris Bormes CEO and President

Keywords: PREAT Corporation, Santa Maria , Regulatory Affairs Specialist, Other , Santa Maria, California

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