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Regulatory Affairs Specialist

Regulatory Affairs Specialist

Requisition ID 
2017-1362
# of Openings 
1
Job Locations 
US-WA-Bothell
Posted Date 
10/4/2017
Category 
Regulatory/Compliance

More information about this job

Overview

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Regulatory Affairs Specialist - Bothell, WA

 

FUJIFILM, SonoSite, Inc . We are an innovative and high performance culture with tremendous opportunities.  People who work here are given the unique opportunity to contribute to the advancement of healthcare throughout the world.  Headquartered in Bothell, WA USA, FUJIFILM SonoSite is represented by a global distribution network in over 100 countries.  Since its inception, FUJIFILM SonoSite’s lightweight, robust products have created and led the point-of-care ultrasound market. From sophisticated urban hospital emergency rooms to clinics in austere, remote villages, FUJIFILM SonoSite systems are used by over 21 medical specialties and provide clinicians around the world with a cost-effective tool for improving patient safety and workflow efficiency. FUJIFILM SonoSite holds a number of prestigious design awards and has in excess of 145 patents.

 

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Job Summary:

 

The  Regulatory Affairs Specialist  is a critical link between FUJIFILM SonoSite, its product development team and regulatory authorities. RA Specialists combine their knowledge of scientific, regulatory, and business practices to ensure FUJIFILM SonoSite is in compliance with the current regulations surrounding marketing, labeling, and legal issues in order to control the marketability of our products.  

 

This position will be responsible for coordinating and executing Class II regulatory submissions to various international regulatory agencies, including FDA (510(k)), Health Canada, European Union (CE mark), TGA (Australia), New Zealand (Medsafe), ANVISA (Brazil), CFDA (China), PAL 3 rd Party (Japan), and others, TBD.  In this role you will work under tight timelines with the regulatory team while maintaining communication with product managers, engineers and RA management.  

 

 

Essential Job Functions:

 

  • Coordinate and prepare product submission packages for regulatory agencies (U.S. and major International markets).
  • Liaise with engineering project managers, distributors, subsidiaries and regulatory agencies.
  • Respond to RA information requests from authorities.
  • Stay abreast of regulatory procedures and changes in regulatory climate.
  • Maintain records on legislation, relations and guidelines.
  • Assist in monitoring and reporting project timelines.
  • Assist in the preparation of routine reports and regulatory agency communications.
  • Maintain regulatory paper and electronic files.
  • Investigate regulatory history of similar products to assess approval implications.
  • Conduct research on submission requirements and options.

 

Knowledge and Experience:

 

  • Requires a Bachelor’s degree with ~ 5 years of related experience in regulatory affairs; or a specialize RA degree with ~2 years regulatory affairs experience.
  • Familiarity with FDA and major international market regulations (Canada, EU, Brazil, Japan, Australia, etc.) is preferred.
  • Experience with FDA Class II devices preferred.

 

Skills and Abilities:

 

  • Excellent analytical and writing skills.
  • Effective interpersonal communication skills.
  • Time and project management.
  • Superior Competency in MS Word, Adobe Acrobat and/or other PDF toolset.
  • Ability to work independently and under pressure (able to prioritize tasks, deadline oriented, good organizational and problem-solving skills, follow-up skills).
  • Committed attention to detail: accurate and meticulous.

 

 

FUJIFILM SonoSite, Incoffers a fantastic compensation package, including benefits, and a 401k program.  Visit us today to learn more about our exciting technologies and how you can make a difference.  To apply and obtain further details regarding key responsibilities and experience requirements, check out our careers page at   www.SonoSite.com/careers.

FUJIFILM SonoSite, Inc.   is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age, protected veteran status, disability status, or any other characteristic protected by law. 

In compliance with the ADA Amendments Act, should you have a disability that requires assistance and / or reasonable accommodation with the job application process, please contact the Human Resources department via phone at 425-951-1200, or via e-mail at ffss-hr@fujifilm.com .   Additionally, the affirmative program/plan is available for review upon formal request by employees and applicants for employment in the Human Resources office during regular office hours.