Regulatory Scientist

Posting Date 1 week ago(7/21/2021 8:25 AM)
Requisition ID
2021-9314
Job Location(s)
Bloomington IN United States
Shift Type
First
Position Type
Full Time
Company
Cook Inc.
Category
Regulatory Affairs

Overview

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.

Responsibilities

• Must be able to rapidly learn new technical subjects and communicate technical and scientific information to project teams and regulatory authorities
• 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 Vice President of Regulatory Scientific Affairs 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

Qualifications

Minimum Work Experience/Educational Requirements

 

• 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/Work Environment

 

• 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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