Job description

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 looking for a Regulatory Specialist I. The Regulatory Specialist I will assist and coordinate the compiling, preparation and assembly of regulatory submissions 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, IVDD 98/79/EC, ISO 14971, Canadian Medical Device Regulation, and related country regulations for medical devices and in vitro diagnostics. Such and activities include: Technical Files, Risk Management, FMEA, Essential Requirements/ GSPR, outside reference standards and various regulatory external and internal support as required.

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

• Understanding, implementation of all the regulations assigned in each country in which products are registered and distributed.
• Assisting in insuring that regulations related to in-country registration is to clearly stated to ensure compliance with product registration for new or registered products.
• Assisting 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 Website

Required Skills/Education

• B.S. or B.A. preferred
• Two to Three years of direct Quality Assurance and Regulatory experience in the medical device and/or pharmaceutical industry.
• GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, MDR 2017/745, ISO harmonized standards (EN14971, EN 13408, EN 13824).
• 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 Acrobat.
• Ability to write, edit, speak and read English well.

EEO/COVID/AGENCY NOTES

Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.

In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. For all positions, the Company encourages vaccination against COVID-19 and may require that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

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.

Job Type: Full-time

Pay: $75,000.00 - $85,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Santa Ana, CA 92705: Reliably commute or planning to relocate before starting work (Required)

Work Location: Hybrid remote in Santa Ana, CA 92705

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