Biocompatibility Scientist

Posting Date 3 weeks ago(11/8/2021 2:35 PM)
Requisition ID
2021-9802
Job Location(s)
Bloomington IN United States
Position Type
Full Time
Company
Cook Medical Holdings
Category
Regulatory Affairs

Overview

The Biocompatibility Scientist at Cook Inc. is responsible for working collaboratively with other biocompatibility specialists, regulatory scientists, toxicologists, engineers, project management, and internal and external stakeholders to develop biological evaluations and safety assessments for devices.
This position will ensure that the Cook Biocompatibility program is compliant to applicable regulatory requirements. This position will establish and maintain a biological evaluation program that utilizes risk management according to relevant regulatory requirements. This position will improve the biological evaluation process using databases, information systems, and training programs. This position will provide technical leadership to engineers and internal and external stakeholders to ensure the material selection and device configuration are biologically safe for existing products and new product development.

Responsibilities

• Provide biological evaluation reports and safety assessments to achieve ISO 10993 compliance and support product development activities.
• Coordinate biological and chemical testing activities by working with Contract Research Organizations and approved laboratories.
• Provide guidance in product development and material selection to ensure device designs meet biological safety requirements.
• Develop or identify resources and provide training in the biological evaluation process.
• 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 biocompatibility.

• Review biocompatibility test plans and reports to determine if correct devices/components/materials are tested. Check for any deviations/test failures/anomalous results and initiate follow-up action.
• Interact with CRO's and testing labs to monitor progress of protocol driven studies.
• Collaborate and take direction, as appropriate, from other Biocompatibility Specialists, Regulatory Scientists, and Engineering personnel to ensure appropriate planning and execution of biocompatibility and chemical analytical tests.
• Assist Biocompatibility Specialists and Toxicologists in procuring adequate documentation that will facilitate development of safety/risk assessments.
• Sound understanding of biocompatibility, toxicology and/or the scientific basis for biological and chemical testing using a risk-based approach.
• Understanding of human health risk assessment concepts & methods.
• 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.

Qualifications

 Bachelor’s degree (or higher) in biomedical engineering, Toxicology, or a relevant life sciences degree.
• Experience in the medical device and/or pharmaceutical industry performing/overseeing biological safety assessments, toxicological risk assessments, and related risk assessments.
• In-depth understanding of ISO 10993 and chemical characterization.
• In-depth knowledge of biological impact of introducing foreign materials into the human body.

 

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.

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