International Affairs Specialist

POSTED: December 4, 2017
BUSINESS: Cook Biotech
POSITION TYPE: Full-time, Exempt
START DATE: Immediate Availability

DUTIES/RESPONSIBILITIES:

The person in this position 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.

  • 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.

REQUIREMENTS/QUALIFICATIONS:

  • Bachelor's degree in Science or Engineering.
  • Master's degree in Science, Engineering or Regulatory Affairs is preferred.
  • A 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.

APPLICATION INSTRUCTIONS: 

Interested candidates please send cover letter and resume to Jordan@cookbiotech.com.

 

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