Regulatory Affairs Specialist II

Posting Date 2 months ago(1/18/2021 11:09 AM)
Requisition ID
2021-8408
Job Location(s)
West Lafayette IN United States
Position Type
Full Time
Company
Cook Biotech Inc.
Category
Regulatory Affairs

Overview

The person in this position will provide support to the Regulatory Affairs department at Cook Biotech Incorporated (CBI). Prepares regulatory submissions including: writing, reviewing, filing and maintaining regulatory, clinical, and design control documents. May also interact and correspond with international regulatory agencies and/or external Cook partners.

 

Responsibilities

  • Independently author high-quality regulatory and/or clinical documents for purpose of gaining and maintaining regulatory approvals in U.S. and international markets.
  • Author scientific/clinical summary documents and/or reviews based on original literature searches.
  • Takes a supportable and defensible position on regulatory matters and writes with compelling logic and in a style appropriate for the reader.
  • Interact, collaborate and provide regulatory advice to staff both internal and external to the Cook organization, including those of marketing partners and third-party distributors.
  • Works closely with product engineering, medical sciences and domestic regulatory teams to ensure consistent regulatory communications. 
  • Remain current and apply the understanding of domestic and international regulations and standards, as well as Quality System requirements in carrying out duties.
  • Offer ideas on the department’s strategic planning and organizing of international projects.
  • Participate in Cook working groups as requested by CBI management.
  • Assist Management with other corporate duties when required.

Qualifications

  • Bachelor's degree in Science or Engineering.
  • Advanced degree in Science, Engineering or Regulatory Affairs is preferred.
  • A current Regulatory Affairs Certification or two (2) years of science, quality or international regulatory and/or technical writing experience is preferred.
  • Scientific and technical writing; making persuasive arguments in a cross-cultural setting.
  • Excellent written, verbal and listening skills, has passion for communicating complex scientific and/or regulatory topics
  • Strong attention to detail and capable of forward-looking critical thinking and problem solving.
  • Broad knowledge and respect of foreign cultures and norms.
  • Strong organizational, follow-up and prioritizing skills.
  • Capable of meeting project deadlines and goals.
  • Experience in using computers for word processing, databases and spreadsheets applications.
  • Able to handle multiple and changing priorities along with fluctuations in workload.
  • Able to travel domestically and internationally
 

 

Physical Requirements/Work Environment

 

  • 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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