FUJIFILM

Regulatory Program Administrator

Job Locations US-Any City | US-MA-Lexington
Posted Date 1 month ago(4/9/2021 6:05 PM)
Requisition ID
2021-14805
Category
Regulatory/Compliance
Company (Portal Searching)
FUJIFILM Medical Systems

Overview

FUJIFILM Medical Systems U.S.A., Inc.  is a leading provider of unrivaled diagnostic imaging products and medical informatics solutions that meet the evolving needs of healthcare facilities today and into the future. Medical imaging solutions span digital radiography (DR), detectors, portables and suites, mammography systems with digital breast tomosynthesis, computed tomography solutions for oncology and radiology applications, as well as technologically advanced flexible and surgical endoscopy solutions. Fujifilm enables interoperability through its Systems Integration offering as well as its comprehensive, AI-supported Synapse® Enterprise Imaging portfolio, which includes the TeraMedica Division of Fujifilm. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Lexington, Massachusetts. For more information please visit www.fujifilmhealthcare.com

 

Job purpose
This position is intended to provide executive level support to the FUJIFILM Medical Systems U.S.A., Inc. (FMSU) Vice President of Regulatory and Quality Affairs and to the FMSU Regulatory and Quality Affairs team at all FMSU business sites. This position is intended to execute FMSU Regulatory and Quality Affairs duties and to facilitate department coordination and cohesion at all FMSU business sites.

External US

Duties and responsibilities

  • Manage the FMSU Regulatory and Quality Affairs Department budget. Identify areas of cost savings and expense reduction. Implement expense controls when required. Collaborate closely with the FMSU Finance team on annual budget creation and any re-budgeting adjustments. Ensure department invoices are approved and paid in a timely manner.
  • Actively participate as a key member of the FMSU Product Safety Committee.
  • Actively participate in and help to coordinate all FMSU United States Food and Drug (U.S. FDA) Inspections and all Notified Body audit activities.
  • Oversee FMSU Regulatory and Quality Affairs Department operational process improvements and efficiency, encourage teamwork and collaboration, process harmonization and optimization.
  • Coordinate the completion and the reporting of the Monthly FMSU Regulatory and Quality Affairs Department Key Performance Indicators (KPI's).
  • Coordinate executive travel arrangements and expense reporting.
  • Maintain the FMSU Regulatory and Quality Affairs team calendar.
  • Maintain the FMSU Regulatory and Quality Affairs organizational chart and help drive department recruitment efforts to successful outcomes.
  • Coordinate FMSU Regulatory and Quality Affairs Department meetings, interdepartmental meetings, FMSU/FUJIFILM Corporation business meetings and other external business meetings as necessary.
  • Review FMSU Regulatory and Quality Affairs Department expense reports and staff time off requests.
  • Other duties as assigned.
  • Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards.

Qualifications

  • Bachelor’s Degree required.
  • Three (3) or more years of  experience performing Regulatory and Quality Affairs support activities in a U.S. FDA regulated environment.
  • Excellent leadership, communication, collaboration, team work and interpersonal skills.
  • Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external).
  • Excellent computer and internet search skills.
  • Strong ability to multi-task and to meet business deadlines.
  • Excellent organizational skills with an ability to think proactively and prioritize work.
  • Physical requirements
    The position requires the ability to perform the following physical demands and/or have
    the listed capabilities.
    • The ability to sit up 75-100% of applicable work time.
    • The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time.
    • The ability to stand, talk, and hear for 75% of applicable work time.
    • The ability to lift and carry up to ten pounds up to 20% of applicable work time.
    • Close Vision: The ability to see clearly at twenty inches or less.

TRAVEL:
Occasional (up to 25%) travel may be required based on business need.

 

Equal Opportunity Employer

FUJIFILM is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law

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