Regulatory Affairs Manager

Company: Fujifilm Irvine Scientific

Position: Regulatory Affairs Manager

Location: Santa Ana, CA

Posted: April 22, 2021

Overview

Irvine Scientific, a member of Fujifilm Holdings Corporation, 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 cell therapy and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large- scale production of biotherapeutics and vaccines. 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 45 years, Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. Additional information can be found at www.irvinesci.com.

 

We are hiring for a Regulatory Affairs Manager. The Regulatory Affairs Manager ensures that products, processes, and procedures are sufficiently controlled to assure the quality of products and compliance in accordance with GMP, ISO 13485, MDD 93/42/EEC, MDR 2017/745, IVD 98/79/EC/ IVDR 2017/746, ISO 14971, and Canadian Medical Device Regulation. In addition, this person will assist and coordinate the compiling, 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, MDR 2017/745, IVD 98/79/EC, IVDR 2017/746, ISO 14971, Canadian Medical Device Regulation, and related country regulations for medical devices and in vitro diagnostics. Such activities include: Technical File creation and preparation, Risk Management, FMEA, Essential Requirements, GSPR, outside references and various regulatory external and internal support as required. The Regulatory Affairs Manager must ensure that requirements are met in all regulatory and registration functions as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC, IVDR 2017/746, Health Canada MDR and related medical device and in vitro diagnostics requirements in all countries where product is registered and distributed.

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Responsibilities:

  • Ensure compliance of all processes and procedures to applicable standards
  • Communicate with regulatory agencies, notified bodies, and competent authorities
  • Prepare and maintain product registrations that include, but are not limited, to the following:
    • Substantial changes and new product submissions
    • 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
  • Oversee, manage and assist with the following activities:
    • 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
  • Provide regulatory approval for the following, but not limited to:
    • Non-conformances
    • CAPA
    • Quality Planning
    • Risk Assessments
    • Document Changes (SOPs, labeling, etc.)
  • Assist in the assessment of Technical Department (R&D) activities that include, but are not limited to, the following:
    • MDR, MPR and/or vigilance investigations for complaints
    • Risk Management File Review and revision based upon complaint
  • Maintain all applicable licensing including:
    • 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

 

Experience/ Education:

  • Bachelor’s degree, preferably in Microbiology, Biology, Chemistry, or similar field
  • Five (5) years’ experience in Quality Assurance/Quality Control/Regulatory Affairs in a medical device discipline
  • 2+ years of supervisory experience
  • Thoroughly knowledgeable in requirements of GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC
  • Knowledge of Quality Control Methodology, QA control systems and production methodologies
  • Ability to interpret regulatory standards, guidance, and laws
  • Industrial or academic experience in cell, tissues culture and/or embryology
  • Ability to obtain cooperation from other groups and lead cross functional teams
  • Experience with risk management and Failure Mode Effects Analysis (FMEA)

 

Apply online at https://uscareers-fujifilm.icims.com/jobs/14373/regulatory-affairs-manager/job?mode=apply&iis=OCRA

 

Irvine 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.