Regulatory Affairs Specialist II

• 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.

• 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.