Regulatory Scientist

Posting Date 3 weeks ago(10/6/2021 8:19 AM)
Requisition ID
2021-9661
Job Location(s)
West Lafayette IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Biotech Inc.
Category
Regulatory Affairs

Overview

Primary Function

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technical documents related to: bench testing pre-clinical testing; clinical evaluations (including published and unpublished scientific articles from various sources); and submissions to regulatory agencies for the primary purpose of gaining approval or clearance to market medical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

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.
  • Takes a supportable and defensible position on regulatory matters and writes with compelling logic and in a style appropriate for the reader.
  • Reviews the work of peers.
  • 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.
  • Authors responses to regulatory agency questions/deficiencies
  • Develops and implements regulatory strategies for new and existing products.
  • Serves as a company representative to the FDA and foreign regulatory authorities as required, both internally and externally.
  • 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 5 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.
  • Must be able to lead and train others in a positive way in concert with the company’s vision.

 

Physical Requirements:

  • Must be able to perform the essential functions of the job, with or without reasonable accommodations.
  • 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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