Clinical Affairs Specialist (Must have CER experience) at FISI - FUJIFILM Irvine Scientific

We are hiring a Clinical Affairs Specialist. The Clinical Affairs Specialist will be responsible for assisting in the development and generation of Clinical Evaluation Plans and Reports (CEPs, CERs), conducting clinical literature searches, performing analysis of clinical literature, and evaluating and reviewing clinical data, generated both pre and post-market for medical devices and in vitro diagnostic devices. In addition, the Clinical Affairs Specialist will assist in performing annual activities associated with Post Market Surveillance (PMS) program, including but not limited to, preparing and writing plans, reports and Post Market Clinical Follow-Up (PMCF).

Company Overview

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. 

Job Description

Responsibilities

• Collaborate on project schedule, timelines and project tracking tools for Clinical Evaluation, PMS and Post Market Clinical Follow-up (PMCF) processes for all medical devices and IVDs.
• Assist in the development and preparation of the Clinical Evaluation Plan and Clinical Evaluation Reports (CERs) per MDR 2017/745 and MEDDEV2.7.1 to meet essential requirements in support of submission for CE mark application to obtain Declaration of Conformity and EU market clearance, recertification and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance (class IIb and III products)
• Assist in providing evaluation of clinical and safety data assessments of post-marketing events.
• Assist in creation of PMCF plans and reports, and Summary of Safety and Clinical Performance (SSCP) documents
• Conducts systematic, comprehensive searches of published clinical literature; assists in writing clear and effective generation of search protocols and reports, examination of clinical evidence and provide input to risk assessment and product labeling as well as clinical / regulatory strategies
• Stay current on clinical research and developments as well as literature related to FUJIFILM Irvine Scientific Products. Provide critical analysis and summary as needed.
• Assist with collecting, analyzing, trending and reporting on safety data to proactively identify potential adverse safety risks or performance trends.
• Ensure, in conjunction with R&D and other personnel, that the clinical requirements of the product are adequately addressed
• Assist with organization and execution of pre-launch clinical usability trials in conjunction with R&D, as needed
• Collaborate with cross-function team members to ensure compliance to applicable regulations, standards, and company policies.
• Preparation of relevant information / responses for regulatory submissions, working with other members of the RA department
• 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
  • Technical Files for EU and EU AR

• Assist with, but not limited to, the following:
  • Internal/External and Customer Audits, as it relates to clinical data
  • Change assessment to product design, specifications, or product manufacturing processes
  • Writing and/or revising regulatory related standard operating procedures
  • Preparing monthly reports on product registration status
• Collaboratively provide clinical expertise including establishing and approving scientific methods for design and implementation of clinical protocols, data collection systems and reports/data presentations/publications
• Perform periodic reviews of risk documentation, product labeling, and marketing brochures as part of the clinical evaluation process.

Required Skills/Education

• B.S. or B.A. required. 
• A minimum of 1-2 years of combined experience in clinical research, medical writing, clinical science in the medical device and/or pharmaceutical industry
• Familiarity with clinical trial design, conduct, and oversight
• Experience in EU Class III products and clinical trials a plus
• Experience/knowledge in writing CERs and/or PMS plans in accordance with Meddev 2.12.2 and MDR
• GMPs, FDA CFRs, USP, ISO 13485, CMDR, MDR 2017/745, IVDD 98/79/EC, IVDR 2017/746, ISO harmonized standards (EN14971, EN 13408, EN 13824).
• Ability to interpret regulatory standards, guidance and laws.
• Knowledge in writing clinical study reports, integrated summaries of safety and performance, abstracts, manuscripts, clinical risk/benefit analyses or literature summaries.
• Strong scientific and medical writing skills.
• Exceptional ability to manage multiple projects in a fast-paced environment, with changing priorities and significant time pressures
• Strong written and verbal communication skills.
• Proficient in Microsoft Word, Excel, PowerPoint, Adobe Acrobat.
• Ability to obtain cooperation from other groups and lead cross functional teams.
• Experience in cell, tissues culture and/or embryology, a plus. Experience can be from education or industry
• 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 $100,090 to $130,295 annually. 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

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.

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EEO Information

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.

ADA Information

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 (