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).

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.

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 and/or pharmaceutical industry.
• Master's degree or Ph.D. preferred.
• 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.
• 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.
• 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 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:

• $112,700 to $202,900 annually depending on experience.
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).

EEO/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.

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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