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The Panther Group
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https://www.thepanthergrp.com
https://www.thepanthergrp.com
USD
52.00
HOUR
true
John Sabbagh
Chemist
Posted: 11/21/2024
2024-11-21
2025-01-01
Employment Type:
Contract
Job Number: 42637
Pay Rate: 52.00
Job Description
CHEMIST
RESPONSIBILITIESÂ
RESPONSIBILITIESÂ
- Knowledgeable in biocompatibility standards and requirements for marketing medical devices globally (USA, Europe and other countries)
- Collaborate effectively with team members from various disciplines globally to develop biocompatibility testing strategies to qualify medical device product
- Review, assess and address any gaps for legacy devices and related documentation to ensure biocompatibility compliance and appropriate
- Regulatory and Quality (e.g. MDR) compliance. Work closely with supervisor to determine potential regulatory risks associated with proposed biocompatibility test strategy and reviewing test protocols from contract labs
- Collaborate with Biocompatibility team members for alignment with testing strategies
- Coordinate testing through outside laboratories by preparing test samples, submission forms, monitor chemical testing or biological studies, review reports generated by outside laboratories and generate final summary report
- Author Toxicological Risk Assessment Reports for extractables/leachables,
- Biocompatibility Risk Assessment Reports for CE Mark and US FDA 510 K
- Submissions Work must show accuracy, attention to detail, completeness of documentation, and be well organized.
- Support interactions with regulatory bodies related to available biocompatibility data for a product
- Support development and maintenance of biocompatibility documents to support EU Medical
- Device Regulations (MDR) Technical Files Appropriately prioritize assignments to meet project schedules
- Responsible for meeting scope and timelines of Biocompatibility deliverables to project teams
- Understanding of principles, and techniques of toxicology and biocompatibility 3-5 years of experience in medical device industry or biocompatibility research organization working on biocompatibility of medical device
- Deep working knowledge of ISO 10993 standards for biocompatibility Ability to coordinate work through outside service laboratories (e.g. extractables/leachables testing and non-clinical safety studies)
- Experience with sample preparation/extraction/ separation techniques for material analyses
- Experience in polymers, analytical chemistry Experience in instrumentation analysis – e.g. FTIR, HPLC, GC, IC, ICP-MS, GC/MS spectroscopic techniques
- Experience interpreting laboratory data and working with mathematical concepts relevant to chemical or biological testing
- Experience reading, analyzing, and interpreting common scientific and technical journals/literature, scientific procedures and regulatory guidelines and writing technical reports, toxicological risk assessment or biocompatibility evaluations
- Experience working in Design Control environment; Auditing Skills, Knowledge of quality systems and regulatory submissions
- Strong oral and written communication skills
- Ability to multitask and track multiple projects at various stages
- Attention to detail
- Critical thinking skills to Interpret available data and recommend strategies to resolve technical challenges.
- Strong computer and general software skills
- Â Bachelors Degree in Biological Sciences or Toxicology or Chemistry with courses in Life Sciences
Meet Your Recruiter
John Sabbagh
Recruiting Manager
John Sabbagh has over 10 years of recruiting experience. Starting his career as an Entry Level Recruiter at Panther, our candidates find him genuine and great resource to their career search!
Fun Fact: John is a sports fanatic, he plays in horseshoe and cornhole leagues and loves fantasy football.
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