Regulatory Scientist

Posting Date 2 months ago(4/22/2021 10:11 AM)
Requisition ID
Job Location(s)
Bloomington IN United States
Position Type
Full Time
Cook Inc.
Regulatory Affairs


The Regulatory Scientist  develops and prepares technical content of documents related to testing of Class III and higher complexity Class II medical devices submitted to regulatory authorities.


• Must be able to rapidly learn new technical subjects and communicate
technical and scientific information to project teams and regulatory
• Write clear and accurate descriptions of non-clinical testing and clinical
studies of new medical products that will be used in support of FDA and
Design Dossier submissions
• Review requisite critical data for completeness and suitability for
submission to regulatory authorities domestic and abroad as required
• Maintain knowledge of federal, state and local regulatory requirements
applicable to pre-market submissions for medical devices
• Develop and implement testing and regulatory strategies for new
medical devices
• Assess new technologies for regulatory pathways
• Coordinate with product development, non-clinical and contract research
organizations as needed for meeting project completion target dates

• Collaborate with Global Regulatory Science Director to
achieve appropriate review, technical accuracy and submission quality
as necessary
• Provide leadership/mentoring for Associates and Specialists
• Must work and interact effectively and professionally with and for others
throughout 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 and
independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations



• Ph.D. in Science or Engineering, or Masters degree with five years
minimum experience with a preferred degree in a Biological Science,
Anatomy or Biomedical Engineering
• Basic understanding of statistical methods and analysis


Physical Requirements:

• Works under general office environmental conditions
• Sitting for extended periods, utilizes close visual acuity for working
with computers, etc.


- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA


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