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Biotechnology, Medical Device, Quality/Risk Management, Worldwide Regulatory Affairs
4 Year Degree
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.
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
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:
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
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
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)
Internal Number: 2021-14373
About FUJIFILM Irvine Scientific
FUJIFILM Irvine Scientific is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivalled 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.