Regulatory Scientist

Posting Date 1 month ago(9/17/2021 11:56 AM)
Requisition ID
2021-9562
Job Location(s)
West Lafayette IN United States
Position Type
Full Time
Company
Cook Advanced Technologies
Category
Regulatory Affairs

Overview

An exciting career opportunity is currently available to join an organization involved in the research, design, and development of novel medical devices.  This job function will organize regulatory efforts throughout all phases of product research and development, and will author/co-author the necessary regulatory submissions to advance products to clinical evaluation or approval.  The function will primarily be involved with projects in early research and development phases, undergoing initial or early clinical trials both in the US and OUS.

Responsibilities

  • Provide organization, coordination, and leadership from a regulatory point of view to a project team pursuing approval of new medical devices
  • Provide regulatory-based guidance through all phases of a project: research and development, pre-clinical and clinical testing, and final data analysis and submission
  • Collaborate with and mentor technical personnel regarding regulatory matters
  • Coordinate and conduct the preparation of well-organized regulatory submissions
  • Author/co-author regulatory submissions in support of engineering projects
  • Ensure work is reviewed with project leaders, regulatory peers, and quality team members

Qualifications

  • M.S. in science or engineering or equivalent industry experience
  • Minimum of two years of experience in leading and/or organizing a project team in the approval process of medical devices from either an industry or regulatory authority viewpoint
  • Familiarity with the components of regulatory submissions, particularly IDEs, PMAs, 510(k)s, INDs, and NDAs
  • Basic understanding of statistical methods and analysis
  • Must be authorized to work in the USA without employer sponsorship, now or in the future

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