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Regulatory Affairs Specialist


Location: Canoga Park, California
Job Category:

Regulatory Affairs Specialist 
Canoga Park, CA
 

A minimum of a Bachelors Degree in science or life science is required.

Minimum of 3 years experience in the device/diagnostic area of regulatory affairs .


Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP), and Quality System Regulations (QSR); current knowledge of European Medical Device and IVD Directive requirements and European quality system standards.


Knowledge of Canadian and Japanese device regulations desired.
 

Understand and interpret U.S. and International medical device and in vitro diagnostic device regulatory requirements.

 

Must have the ability to develop and maintain excellent working relationships between regulatory and company personnel.

 

Position will be responsible for interacting with company employees on regulatory issues as necessary.  This responsibility entails development , execution, and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business.

Primary job responsibilites:

  • Preparation of regulatory affairs submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets..
  • Ensure that the product development process, including clinical studies, addresses all regulatory requirements.
  • Provide guidance for compliance to current regulations and assist management in planning regulatory strategies for new products.
  • Provide input for regulatory requirements and regulatory registration strategy for product development and product changes to ensure timely submission and approval.
  • Provides regulatory opinions in premarket regulatory requirements, export, and labeling requirements.
  • Communicate submission and/or advertising and promotion requirements to product development teams.
  • Assist in the regulatory documentation requirements for New Product Development.
  • Maintains all Regulatory Affairs documentation/files.
  • Assures that all submission documentation, record keeping and reporting meet inspection standards in accordance with regulatory requirements.
  • Responsible for the tracking and trending of post market vigilance information for risk management reviews.

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