Senior Biological Safety Scientist / Toxicologist
Responsibilities To perform this job successfully, an individual must be able to perform each essential duty satisfactorily, which includes but not limited to the following:
Assess existing products for compliance to international biological safety standards Assign product classifications according to category of patient contact and duration Develop biological testing strategies based on regulations and internal procedures Manage CRO biological and toxicological testing, including protocol assessments, to complete testing within budget and schedule Interpret biological and toxicological study completion reports, understanding their strengths and weaknesses Perform toxicological and biological risk assessments based on extractables and chemical residues found in the device. Write toxicological risk assessments, based on hazard identification, route of exposure and dose - response. Extrapolate toxicological animal data to humans as well as data from one route of exposure to another. Write overall biological safety assessments as a design verification activity in the context of overall risk management Perform technical and product-related sustaining activities using knowledge of biomaterials, Design Controls, scientific principles and compliance writing Perform all other duties as required Qualifications The requirements listed below are representative of the knowledge, skills, and/or abilities required for this position:
PhD in Toxicology, Environmental Health or related field with 3-5 years' experience in the field. Experience in conducting toxicological and biological risk assessments. Experience in working with submissions for the FDA and notified bodies is preferred. An understanding of biological safety regulations relating to medical devices is preferred. Product development experience is desirable. Experience in contributing to technical and cross-functional teams to advance project goals with notable impact on company objectives. Experience in generating test plans, writing protocols, conducting design verification/validation, and processing validation testing Working knowledge of the U.S. and International standards governing the design, development, testing, and manufacture of medical devices Experience/familiarity with U.S. FDA, GMP, and ISO requirements for the design, validation, manufacturing processes, and assembly of medical components and devices The ability to travel up to 15%
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Assess existing products for compliance to international biological safety standards Assign product classifications according to category of patient contact and duration Develop biological testing strategies based on regulations and internal procedures Manage CRO biological and toxicological testing, including protocol assessments, to complete testing within budget and schedule Interpret biological and toxicological study completion reports, understanding their strengths and weaknesses Perform toxicological and biological risk assessments based on extractables and chemical residues found in the device. Write toxicological risk assessments, based on hazard identification, route of exposure and dose - response. Extrapolate toxicological animal data to humans as well as data from one route of exposure to another. Write overall biological safety assessments as a design verification activity in the context of overall risk management Perform technical and product-related sustaining activities using knowledge of biomaterials, Design Controls, scientific principles and compliance writing Perform all other duties as required Qualifications The requirements listed below are representative of the knowledge, skills, and/or abilities required for this position:
PhD in Toxicology, Environmental Health or related field with 3-5 years' experience in the field. Experience in conducting toxicological and biological risk assessments. Experience in working with submissions for the FDA and notified bodies is preferred. An understanding of biological safety regulations relating to medical devices is preferred. Product development experience is desirable. Experience in contributing to technical and cross-functional teams to advance project goals with notable impact on company objectives. Experience in generating test plans, writing protocols, conducting design verification/validation, and processing validation testing Working knowledge of the U.S. and International standards governing the design, development, testing, and manufacture of medical devices Experience/familiarity with U.S. FDA, GMP, and ISO requirements for the design, validation, manufacturing processes, and assembly of medical components and devices The ability to travel up to 15%
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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