We are hiring a Sr. Manager, Regulatory Affairs. The Sr. Manager, Regulatory Affairs will be responsible for ensuring that product, process, 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 D 98/79/EC, IVDR 2017/746, and Canadian Medical Device Regulation. Such and activities include writing, managing and leading preparation, creation and revisions of: Technical Files, Risk Management, Clinical Program, FMEA, Essential Requirements/ GSPR, outside reference standards and various regulatory external and internal support as required. The Sr. Manager, Regulatory Affairs oversees and manages complete product lifecycle from design control through post market to ensure compliance of regulated products, medical devices and IVDs in the US, EU and Canada.

FUJIFILM Irvine Scientific, Inc. is a global leader in the innovation and manufacture of cell culture solutions for Life Science and Medical markets, providing products and services that assist customers in advancing healthcare initiatives. Working across discovery research, cell and gene therapy, reproductive medicine and cytogenetics, as well as the large-scale production of biotherapeutics and vaccines, the Company is trusted by researchers, manufacturers, and clinicians worldwide. For over 50 years, FUJIFILM Irvine Scientific’s Mission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in its products and custom solutions, providing customers with the vital resources needed to enrich human lives through innovative, accessible therapies. The Company’s facilities adhere to both ISO and FDA regulations, with manufacturing facilities that follow cGMP guidelines in the USA, Japan, and the Netherlands, and a media optimization center in China. All sites prioritize strategies that adhere to the FUJIFILM Sustainability Value Plan 2030 for sustainable growth. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation. 

Responsibilities 

• Manage and coordinate the renewal and maintenance of, but not limited to, the following:
• Local, State and National Regulatory licensing and registration renewals
• Import/Export Permits
• Manage and coordinate the identification and assessment 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
• Manage and coordinate 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
• Manage and coordinate, 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
• Manage and coordinate the approval and evaluation of, but not limited to, the following:
• Changes to procedures
• Product promotional material
• Product IFUs
• Irvine Scientific Website
• Manage, coordinate and oversee Clinical Program, including but not limited to:
• Development of CEP and CERs compliance to regulations
• Post Market Surveillance program including PMCF and PMS

Required Skills/Education 

• Prefer B.S. or B.A. in Microbiology, Biology, or Chemistry.
• Five (5) years experience in Quality Assurance/Quality Control/Regulatory Affairs in a medical device discipline.
• 2+ years of supervisory experience
• GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, MDR 2017/745, IVDR 2017/746, 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, a plus. 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).
• Proficient in Microsoft Word, Excel, PowerPoint, Adobe Acrobat.
• Strong written and verbal communication skills.
• Exceptional ability to manage multiple projects in a fast-paced environment, with changing priorities and significant time pressures
• Strong scientific and medical writing skills.
• Knowledge in writing technical documentation, clinical study reports, integrated summaries of safety and performance, abstracts, manuscripts, clinical risk/benefit analyses or literature summaries.
• Must be able to work and make independent decisions, understand complex scientific and clinical data information, and be able to take the initiative to lead projects and assignments.
• Ability to write, edit, speak and read English well.

Salary and Benefits:

• For California, the base salary range for this position is $119,635 - $167,607. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

*#LI-hybrid

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (fisihr@fujifilm.com).