Upgrade Post project

Senior Regulatory Specialist

Los Angeles  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

A Global Medical Device company is seeking a pre-market Regulatory Affairs Senior Specialist to join their growing team. The Senior Specialist will be responsible for developing and authoring 510(K), PMA, IDE or HDE submissions.

Responsibilties:
  • Develop regulatory strategies for new product development or product changes
  • Author IDE, 510(K), PMA or HDE submissions for multiple product lines
  • Provide input to development teams about the regulatory impact of product changes
  • Interact with FDA regarding the submission and feedback of regulatory filings


    • Requirements:
  • 4+ Years of Regulatory Affairs experience in the medical device industry
  • Bachelor's Degree
  • Experience with 510(K), PMA or IDE submissions
    • Start date
    08/2014
    From
    Real Staffing
    Published at
    27.08.2014
    Project ID:
    764737
    Contract type
    Permanent
    To apply to this project you must log in.
    Register