Cook Medical Regulatory Science Specialist in bloomington, Indiana
The Regulatory Science Specialist assists in the preparation of routine and non-routine regulatory submissions of Class III and higher complexity Class II medical devices submitted to regulatory authorities. The Regulatory Science Specialist will interact with representatives from other functions and/or serve as the regulatory member on project teams.
• Prepare regulatory product approval submissions for new and modifiedmedical devices• Provide support to pre-clinical testing and clinical studies of new and modified medical devices• Review requisite critical documentation for completeness and suitabilityfor submission to regulatory authorities, both domestic and abroad asrequired• Collaborate with Regulatory Scientists, Director, Regulatory Science and other technical staff to develop and implement testing and regulatory strategies for new and existing medical devices• Collaborate with Regulatory Scientists and Director, Regulatory Science to identify areas for developing technical expertise that would be utilized by various functions within Cook
• Must work and interact effectively and professionally with and for othersthroughout various levels of the global organization• Must strictly adhere to safety requirements• Maintain regular and punctual attendance• Must maintain company quality and quantity standards• Must have effective oral and written communication skills• Excellent problem solving skills and ability to work in collaborative andindependent work situations and environments with minimal supervision• Ability to remain calm and receptive in fast paced situations
Minimum Work Experience/Educational Requirements
• PhD in Science or Engineering, or Master Degree in Science orEngineering with 2+ years experience in regulatory applications in themedical device industry required• Preferred degrees include Chemistry or Biological Science,Anatomy/Physiology, or Biomedical Engineering
Physical Requirements/Work Environment
• Works under general office environmental conditions• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
Job Location(s)Bloomington IN United States
Position TypeFull Time