Regulatory Affairs Specialist - Post Market 7/31/2018

Toshiba America Medical Systems, Inc. Tustin, CA

Tustin, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)
Associates Degree


Job Summary

Reporting to the Manager Regulatory Affairs the Regulatory Affairs Specialist is responsible for complaint handling, coordination of product recalls, Field Modification Instructions (FMI) processes, processing electronic submissions and state registrations.

Essential Responsibilities

* Coordinate the complaint handling process to include processing of reportable events
* Provide information as requested for the filing of FDA recalls
* Coordinate FMI process, including monitoring and reporting status and completion.
* Process electronic submissions (e.g. 3500A, 2579, Product Reports, Annual Reports)
* Coordinate state registrations, including monitoring regulations and preparing and submitting documentation to each state as required.
* As requested, write Canon Medical Systems USA (CMSU) policies, procedures and guidance documents incorporating regulatory requirements/actions.
* Assist in maintaining proper preparedness for State or Federal (FDA) authorities.
* Represent interests of Regulatory Affairs in cross functional teams as needed.

Position Requisites

* Two years regulatory experience required. Experience in regulatory affairs for medical device industry preferred.
* Associate's degree with experience required. Bachelor's degree in business, engineering or science related preferred.
* Excellent interpersonal, communication, and organizational skills.
* Ability to develop and maintain effective working relationships internally and externally.
* Good PC skills, including MS Word, Excel, Oracle, Sales Force, etc.
* Medical Device experience a plus.


Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled