Regulatory Scientist

Posting Date 2 months ago(4/1/2022 8:25 AM)
Requisition ID
2022-10568
Job Location(s)
West Lafayette IN United States
Position Type
Full Time
Company
Cook Biotech Inc.
Category
Regulatory Affairs

Overview

Writes, reviews, and maintains Cook Biotech Inc. technical documents related to: bench testing pre-clinical testing; clinical evaluations (including published and unpublished scientific articles from various sources); and supports submissions to regulatory agencies for the primary purpose of gaining approval or clearance to market medical devices.


 

Responsibilities

  • Writes clear and accurate descriptions of testing and performance of medical devices suitable for regulatory agency review, including but not limited to: Clinical Evidence Reports (CERs), Investigational Device Exemption (IDE) requests, Biological Safety Evaluation Reports (BSERs), 510(k) submissions and PMAs for US submissions or the equivalent sets of documents for OUS submissions.
  • Prepares documentation for submission to regulatory agencies.
  • Maintains records of technical documents sent to regulatory agencies.
  • Prepares well-organized, complete, and persuasive position papers/statements where needed.
  • Assesses new technologies and practices for regulatory impact.
  • Works closely with product development, pre-clinical, clinical and research teams.
  • Manages projects and assures communications within and between project teams to provide guidance, issue resolution, insight, and strategic decisions.
  • Provides well-reasoned and defensible opinion on matters of concern to the company by the application of not only scientific logic, but also judgment, wisdom, reason, practicality and insight.

Qualifications

  • Holds a MS in science or engineering (any additional relevant experience would be very highly considered) or a BS with a minimum of 1 years of directly applicable regulatory experience specific to the medical device industry.
  • Maintains knowledge of European, federal, state and local requirements applicable to the performance of regulatory affairs tasks related to pre-market submissions for medical devices, with specific expertise in either European or US requirements.
  • Excellent oral, written, computer and interpersonal skills.
  • Ability to rapidly learn new technical subject matter that may be unrelated to area if formal training.
  • Ability to effectively and accurately communicate technical, medical and scientific information.
  • Must be self-motivated and able to work with a minimum of supervision either alone or in a team environment.

 

Physical Requirements:

• Limited exposure to hazardous chemicals used in the manufacture of the product

• Physical demands are typical of an office and classroom environment

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