Regulatory Scientist

Posting Date 3 weeks ago(5/7/2022 9:29 PM)
Requisition ID
Job Location(s)
Bloomington IN United States
Shift Type
Position Type
Full Time
Cook Medical Inc.
Regulatory Affairs


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.


• 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
• 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


Minimum Work Experience/Educational Requirements

• 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/Work Environment

• Sign non competition and confidentiality agreements. Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Cook Electronic Information Policy, Product Complaints, HIPAA regulations and Cook Policy & Guidance On Interaction with Healthcare Professionals

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





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