Materials and Regulations Scientist

Posting Date 4 days ago(11/22/2021 9:09 PM)
Requisition ID
2021-9804
Job Location(s)
Bloomington IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Medical Holdings
Category
Engineering

Overview

The Materials and Regulations Scientist at Cook Medical is responsible for working collaboratively with biocompatibility specialists, regulatory scientists, toxicologists, engineers, project management, and internal and external stakeholders to develop regulatory submission documents that contain proper material information.


This position will ensure the Cook organization is compliant to applicable regulatory requirements including both material regulations as well as biocompatibility standards. This position will support the development of a material program that issues corporate level policies and procedures to standardize the management of material information. This position will improve the material evaluation process by establishing new criteria for databases, information systems, and training programs. This position will provide technical leadership to engineers and internal and external stakeholders to ensure the material selection is appropriate for both regulatory and design requirements for existing products as well as new product development.

Responsibilities

• Support material information organization to effectively respond to material information requests throughout the organization
• Provide guidance in product development and material selection to ensure device materials meet global material regulation criteria as well as design requirements
• Assist in device design change evaluation related to supplier-initiated and Cook-initiated changes
• Assist in responding to deficiency responses from regulatory agencies related to material information
• Track material compliance requirements with appropriate medical device standards and regulations
• Serve as a technical lead on materials-related projects
• Research and develop technical white papers to disperse material knowledge across the organization
• Support development of corporate level policies and procedures to standardize the approach to management of raw materials

• Collaborate and take direction, as appropriate, from Biocompatibility Specialists, Regulatory Scientists, and Engineering personnel to ensure appropriate and timely execution of regulatory submission documents
• Assist Biocompatibility Specialists, Toxicologists and Engineers in procuring adequate documentation that will facilitate development of safety/risk assessments
• In-depth understanding of ISO 10993 and chemical characterization
• In-depth knowledge of common medical device materials (polymers) and additives
• Experience with analytical material characterization (DSC, TGA, FTIR, MI, etc.)
• Demonstrated ability to manage and execute multiple projects
• Understanding of applicable guidelines and regulations
• Ability to read, write, and compile technical documents
• Ability to work collaboratively with team members in a local and global environment
• Excellent analytical and problem-solving skills
• Effective oral, written and presentation communication skills
• Enthusiastic to be mentored/developed by experienced individuals in the biocompatibility & toxicology team

Qualifications

• Bachelor’s degree in material science, chemistry, chemical engineering or a relevant life sciences degree
• Master’s degree preferred
• Minimum 3 years experience in the medical device and/or pharmaceutical industry with exposure to material regulations such as EU MDR, REACH, Prop 65, RoHs

 

Physical Requirements:

• Works under general office environmental conditions
• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Frequently required to sit, stand, walk, and communicate
• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Ability to travel over-night up to 10% of time, if needed

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed