Regulatory Scientist

Posting Date 4 weeks ago(9/2/2020 10:49 AM)
Requisition ID
2020-7707
Job Location(s)
West Lafayette IN United States
Position Type
Full Time
Company
Cook Biotech Inc.
Category
Regulatory Affairs

Overview

The Regulatory Scientist at Cook Biotech writes, reviews, submits and maintains technical documents, and develop and executes strategies related to submissions to regulatory agencies for the primary purpose of gaining approval or clearance to market medical devices. 

Responsibilities

• Develops and executes efficient regulatory strategies for new and existing products leading to approvals/clearances for Class II and III implantable medical devices
• Authors medical device submissions including but not limited to: IDEs, 510(k)s, and PMAs for US or equivalent European submissions
• Takes a supportable and defensible position on regulatory matters and writes with compelling logic and in a style appropriate for the reader
• Maintains records of technical documents sent to regulatory agencies
• Serves as a company representative to the FDA and foreign regulatory authorities as required, both internally and externally

• Works closely with engineers and scientists in product development, pre-clinical, clinical and research teams to ensure regulatory compliance and new product approval
• Reviews and provides strategic feedback on engineering and scientific documentation/reports to ensure alignment with regulatory needs 
• Manages projects and assures communications within and between project teams to provide guidance, issue resolution, insight, and strategic decisions
• Provides well-reasoned and defensible opinion on matters of concern to the company by the application of not only scientific logic, but also judgment, wisdom, reason, practicality and insight

Qualifications

• MS/PhD in science or engineering with 2 years or directly applicable regulatory experience (any additional relevant experience would be very highly considered) or a BS with a minimum of 5 years of directly applicable regulatory experience specific to the medical device industry
• Maintains knowledge of US and EU requirements applicable to the performance of regulatory affairs tasks related to pre-market submissions for medical devices, with specific expertise in either US or EU requirements
• Demonstrated regulatory experience in one or more of the following technologies: biomaterials, resorbable/degradable materials, materials of animal origin, regenerative medicine/tissue engineering products, or human tissue products

• Excellent oral, written, computer and interpersonal skills.
• Ability to rapidly learn new technical subject matter that may be unrelated to area if formal training
• Ability to effectively and accurately communicate technical, medical and scientific information
• Must be self-motivated and able to work with a minimum of supervision either alone or in a team environment
• Must be able to lead and train others in a positive way in concert with the company’s vision

 

Physical Requirements:

• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Limited exposure to hazardous chemicals used in the manufacture of the product

• Physical demands are typical of an office and classroom environment
• 100% remote possible depending on candidate

 

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