Clinical Affairs Program Manager

Overview

FUJIFILM Irvine Scientific, Inc. (FISI) 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, regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FISI adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy and expertise in cell culture and compliance provide customers with unique capabilities and support. For over 50 years, FISI 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 hiring a Clinical Affairs Program Manager. The Clinical Affairs Program Manager will be responsible for the development and generation of Clinical Evaluation Plans and Report (CEPs, CERs), clinical literature searches analysis of clinical literature, and evaluation and review of clinical data, generated both pre and post-market for medical devices and in vitro diagnostic devices. In addition, the Clinical Affairs Program Manager will perform 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).

External US

Responsibilities 

• Create and manage detailed 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.
• Developing and prepare 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)
• Provides clinical and safety data assessment of post-marketing events.
• Creates PMCF plans and reports, and Summary of Safety and Clinical Performance (SSCP) documents
• Conducts systematic, comprehensive searches of published clinical literature; writes 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.
• Collect, analyze, trend and report 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
• Manage relationship with CROs, as applicable
• Organize and conduct 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
• 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 

• A minimum of 4 years of combined experience in clinical research, medical writing, clinical science in the medical device