FUJIFILM

Regional Regulatory Affairs Manager

Job Locations US-FL-Miami
Posted Date 1 day ago(6/11/2021 7:40 PM)
Requisition ID
2019-4647
Category
Regulatory/Compliance
Company (Portal Searching)
FUJIFILM Medical Systems

Overview

At FUJIFILM we are constantly looking for great talent to join our team.  If your are interested in joining us for future roles, please share your resume and we'll contact you should the next opportunity arise.  


Regulatory Affairs Coordinator directly reports to the Business Development Manager, will act as a link between our head office, Subsidiaries, OEM partners with our Distributors in Latin America, ensuring  our products are registered in time manner and, are able to be commercialized in compliance with appropriate registration.

 

FUJIFILM Medical Systems U.S.A., Inc. (Fujifilm) is a leading provider of medical image and information products and technologies for acquiring, processing, managing and storing diagnostic images and related data. As the inventor of digital x-ray, over thirty years ago with our Computed Radiography (CR) technology, we have built a reputation as an innovator of healthcare systems that produce superior diagnostic information. As the healthcare segment evolves, we will continue to provide the market with innovative solutions that reach well beyond general radiography.

External US

Main Responsibilities:

  • Facilitate registration of FUJIFILM products in Latin America through distributors in Latin America.
  • Act as a liaison between the manufacturer, OEM Manufacturers sites abroad ( Japan, India, Korea, Italy, China, etc) with Distributors.
  • Responsible to collect list of all necessary document required for sanitary registration in each country, prepare drafts documents that fall in line with the pettioner’s requirement and company policy, submit the dossier to local distributors and monitor the evaluation of registration.
  • To monitor the expiration of product registration to ensure compliance for commercialization
  • Assist in maintaining master regulatory files in accordance 
  • Other tasks and duties may be assigned as deemed necessary.

Additional Responsibilities:

  • Adhere to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties inherent in the position description are performed in accordance with established policies and procedures

Minimum Requirements:

 

  • Working experience for a global medical company
  • Had a position as Regulatory Affair Coordinator 
  • Work with sense of urgency

 

  • Regular business hours basis, but availability to do overtime.

 

  • Ability to manage multiple projects at a time

 

  • Ability to work under pressure and meet short deadlines

 

  •  Be highly organized with keen attention to detail

 

  • More than intermediate level fluency in written and verbal Spanish and English. 

 

  • Effective time management skills 

 

  • Ability to analyze and resolve challenges independently

 

  • Must have strong interpersonal skills, maturity, and good judgment and be capable of communicating with a diverse range of individuals

 

  • Microsoft PowerPoint, Excel, and Word proficiency

 

  • Ability to anticipate the need for proactive communication and planning at all levels

 

This position description contains the general duties considered necessary to outline the principal functions of the job and shall not be construed as inclusive of all work requirements which may be inherent to successful performance. FMSU management reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

 

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.

 

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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