Clinical Affairs Specialist

Regulatory/Compliance | Santa Ana, CA

Job Function:

We are hiring a Clinical Affairs Specialist. The Clinical Affairs Specialist will be responsible for the development and generation of Clinical Evaluation Plans and Reports (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 Specialist 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). The person in this role will ensure that requirements are met in all regulatory and registration functions as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDR 2017/745, IVDD 98/79/EC, IVDR 2017/746, Health Canada and related medical device and in vitro diagnostics requirements in all countries where products are registered and distributed.

Job Duties:

  • 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
  • Develop 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)
  • Provide clinical and safety data assessment of post-marketing events
  • Create PMCF plans and reports, and Summary of Safety and Clinical Performance (SSCP) documents
  • Conduct systematic, comprehensive searches of published clinical literature; write 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
  • 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
  • Prepare 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

Experience/Education:

  • High School diploma required; some college courses in Microbiology preferred, degree in Microbiology ideal
  • 0-1 year of experience doing environmental monitoring in a cleanroom environment or working in a cleanroom environment
  • Knowledge of cGMP and GDP preferred
  • Cleanroom experience preferred
  • Understanding of good lab safety practices
  • Basic understanding of 21CFR211 – cGMP, 21CFR820 - QSR, ISO 13485, Canadian MDR, MDD-93/42 with emphasis on laboratory testing, material specifications, and related areas

#LI-AA1

 

Principals only. No recruiters please.

FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

© 2021 FUJIFILM Irvine Scientific. All rights reserved.