Careers

Regulatory Affairs & Documentation Coordinator

Regulatory | Santa Ana | CA

Job Function:
We are seeking an individual to coordinate and follow-up on requests from Regulatory Affairs departments and outside customers for documentation. Follow up with internal resources to obtain needed documents and date and assists with preparing documents. Support Document Control program. Ensures compliance to ISO13485:2016, QSR, and Canadian Device Regulations.

 

Job Duties:

  • Word process documents.
  • Maintain log of requests and follow-up on status through completion.
  • Support Regulatory Affairs and product registrations.
  • Support document control program.
  • Coordinate and follow-up on responses to documentation requests from Regulatory Affairs department and outside customers.
  • Assist with compiling information needed for product registration and regulatory filings.


Experience/Education:

  • A minimum of two 2 years’ experience of project management, regulatory affairs, or document control in a medical device manufacturing environment or equivalent.
  • Computer skills, specifically MS Word, Excel, Adobe Acrobat.
  • Current industry regulations, i.e. cGMP, ISO 13485, Code of Federal Regulations.
  • High school diploma or equivalent.
  • Ability to speak, write and read English.
  • Good oral and written communication skills.

 

To Apply: Please send resume to: fisiirlrecruitment@fujifilm.com. Please put Regulatory Affairs & Documentation Coordinator 120318 in the subject line.

 

Principals only. No recruiters please.

 

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.


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