International Affairs Specialist

Posting Date 1 month ago(1/19/2018 9:07 AM)
Requisition ID
2018-3647
Job Location(s)
West Lafayette IN United States
Position Type
Full Time
Company
Cook Biotech Inc.
Category
Regulatory Affairs

Overview

The International Affairs Specialist at Cook Biotech Inc. will provide support to the International Affairs department at Cook Biotech Incorporated (CBI). The International Affairs Specialist prepares regulatory submissions including: writing, reviewing, filing and maintaining regulatory, clinical, and design control documents. The International Affairs Specialist may also interact and correspond with international regulatory agencies and/or external Cook partners.

Responsibilities

• Author high-quality regulatory documents for purpose of gaining and maintaining regulatory approvals in countries outside of the United States
• 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 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
• Perform data entry duties in various computer databases
• Mailing, faxing, scanning, copying, and filing documents related to regulatory submissions
• 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; Master's degree in Science, Engineering or Regulatory Affairs is preferred
• Current Regulatory Affairs Certification or two (2) years of science, quality or international regulatory experience is preferred
• Scientific and technical writing; making persuasive arguments in a cross-cultural setting
• Excellent written, verbal and listening skills
• Proficiency in a second language is preferred

• 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:

• 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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