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Regulatory Affairs Specialist II

Company: FISI - FUJIFILM Irvine Scientific
Location: Santa Ana
Posted on: November 12, 2021

Job Description:

Overview FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company---s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.-- FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.We are hiring for a Regulatory Affairs Specialist. The Regulatory Affairs Specialist will assist and coordinate the compilation, preparation and assembly of regulatory submission and support files for medical devices and in vitro diagnostics registration worldwide in accordance with GMP, ISO 13485, MDD 93/42/EEC, IVD D 98/79/EC, ISO 14971, Canadian Medical Device Regulation, and related country regulations for medical devices and in vitro diagnostics. These activities include: Technical Files, Risk Management, FMEA, Essential Requirements, outside references and various regulatory external and internal support as required. The Regulatory Affairs Specialist will ensure that requirements are met in all regulatory and registration functions as prescribed by the FDA---s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada MDR and related medical device and in vitro diagnostics requirements.** External US Responsibilities:

  • Assist in the renewal and maintenance of, but not limited to, the following:
    • Local, State and National Regulatory licensing and registration renewals
    • Import/Export Permits
    • Assist in the identification of, but not limited to, the following:
      • Relevant guidance documents, international standards, or consensus standards and their interpretation as they relate to registration requirements
      • Notification to management of new and revised documents referenced above
      • Assist in the preparation and maintenance of product registrations that include, but are not limited, to the following:
        • Renewal of Technical Files and communication with corresponding Agents (EU AR, China, etc.)
        • US FDA 510(k) Premarket Notifications
        • US FDA Drug Master Files and annual updates
        • Technical Files for EU and EU AR
        • Registration Documents for China and ROW
        • Understand and implement of all the regulations assigned in each country in which products are registered and distributed including, but not limited to, the following:
          • Assist in ensuring that regulations related to in-country registration are clearly stated to ensure compliance with product registration for new or registered products
          • Assist in ensuring that distributors of IS products are observing the regulations as mandated by regulatory authorities in-country, including that of products that are registered
          • Assist with, but not limited to, the following:
            • Internal/External and Customer Audits
            • Change assessment to product design, specifications, or product manufacturing processes
            • New Product Committee (NPC) Design Control
            • Product Recalls
            • Field safety corrections
            • Mandatory Device Reporting (MDR)
            • Mandatory Problem Reporting (MPR)
            • Vigilance Reporting (EU)
            • Adverse Events Reporting (Worldwide)
            • Writing and/or revising regulatory related standard operating procedures
            • Preparing monthly reports on product registration status
            • Assist in the approval of, but not limited to, the following:
              • Changes to procedures
              • Product promotional material
              • Product IFUs
              • Irvine Scientific WebsiteExperience/ Education:
                • Bachelor---s Degree
                • Two to Three years of direct Quality Assurance and Regulatory experience in the medical device and/or pharmaceutical industry
                • Knowledge of GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971, EN 13408, EN 13824)
                • Understanding of quality control methodology, QA controls systems and production methodologies
                • Experience in cell, tissues culture and/or embryology; Experience can be from education or industry
                • Ability to obtain cooperation from other groups and lead cross functional teams
                • Experience with risk management and Failure Mode Effects Analysis (FMEA)
                • Understanding of validation of processes and equipment, methods validations, process investigations, technical evaluation
                • Proficient in Microsoft Word, Excel, PowerPoint, Adobe AcrobatIrvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic--protected by applicable federal, state, or local law.To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Keywords: FISI - FUJIFILM Irvine Scientific, Santa Ana , Regulatory Affairs Specialist II, Other , Santa Ana, California

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