Regulatory Scientist 2

Posting Date 2 months ago(3/28/2022 2:11 PM)
Requisition ID
2022-10542
Job Location(s)
Bloomington IN United States
Position Type
Full Time
Company
Cook Medical Inc.
Category
Regulatory Affairs

Overview

The Regulatory Scientist 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 and will interact with representatives from other functions and/or serve as the regulatory member on project teams.

Responsibilities

• Prepare regulatory product approval submissions for new and modified
medical devices
• Provide support to pre-clinical testing and clinical studies of new and modified medical devices
• Review requisite critical documentation for completeness and suitability
for submission to regulatory authorities, both domestic and abroad as
required
• 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 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

Qualifications

• PhD in Science or Engineering, or Master Degree in Science or
Engineering with 2+ years experience in regulatory applications in the
medical device industry required
• Preferred degrees include Chemistry or Biological Science,
Anatomy/Physiology, or Biomedical Engineering

• Experience learning new technical subject matter that may be unrelated
to area of formal training
• Experience effectively and accurately communicating technical medical
and scientific information to persons without expertise in the subject area

 

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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