| Immediate hiring for Biocompatibility Specialist - Brooklyn Park, MN location at Brooklyn, New York, USA |
| Email: suzanne.rogers@concorditsystems.com |
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From: Suzanne Rogers, Concord IT Systems suzanne.rogers@concorditsystems.com Reply to: suzanne.rogers@concorditsystems.com Hello, Hope you are doing good. Role: Biocompatibility Specialist Location: Brooklyn Park, Minnesota Long term Position Responsibilities: Provides expertise in biocompatibility of medical device materials through knowledge of and experience with biological evaluations in accordance with ISO 10993 and global regulatory filings. Determines biocompatibility testing regimen based on type of patient contact and duration of use. Identifies master devices to be evaluated to represent multiple devices that share design characteristics and use conditions. Collaborates with third party services/test laboratories to obtain quotes and schedule testing. Obtain purchase orders and secure required test devices. Provides expertise to support extractables & leachables testing of products relevant to use conditions. Authors biocompatibility plans and reports complying with applicable biological evaluation standards and FDA/ISO guidance documents within a risk-based framework. Reviews protocols, reports, toxicological risk assessments, and regulatory submission summaries in collaboration with cross-functional team members and test laboratories. Analyzes biocompatibility test results to determine adequacy of data to meet requirements for the biological effects. Utilizes problem solving skills and technical knowledge to troubleshoot unexpected results and make scientifically-based decisions on whether additional testing is warranted. Assist with regulatory submissions to global regulatory agencies in order to elaborate on the biocompatibility strategy and data in response to any additional information requests. Works independently under limited supervision to determine and develop approach to solutions. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Makes improvements of processes, systems or products to enhance performance of the job area. Provides guidance, coaching and training to other employees within job area. Basic Qualifications: IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME Education Required Bachelors Degree in Chemistry, Biology, Biochemistry, Biomedical Engineering with a minor in Chemistry/Biology, or equivalent Years of Experience 4+ years relevant experience with Bachelors 2+ years relevant experience with advanced degree Specialized Knowledge or Skills Required Established knowledge of Analytical Chemistry techniques with application in pharmaceutical and/or medical device industry Experience performing laboratory data interpretation including working with mathematical concepts relevant to the laboratory setting Experience reading, analyzing, and interpreting common scientific and technical journals, scientific procedures and regulatory guidelines. Experience with performing statistical analysis of data Preferred Skill set(s) : Demonstrated excellent written and oral communication skills Experience coordinating work through outside service laboratories Knowledge of quality systems and regulatory submissions -- Thanks and Regards, Suzanne Rogers US IT Recruiter Cell : (312) 585-2508 Desk No.: 17866280721 Email Id: suzanne.rogers@concorditsystems.com Keywords: information technology Idaho https://jobs.nvoids.com/job_details.jsp?id=414211 |
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| 08:30 PM 17-Jul-23 |