Principal Toxicologist - remote
Serve as Subject Matter Expert for internal business partners and product development teams by providing technical expertise for toxicological and biocompatibility processesThis position is responsible for the biological evaluation of medical device, OTC, and cosmetic products, including the conduct of toxicological risk assessments in support of new product development and sustaining activities, as well as in support of global regulatory submissionsThis position ensures product safety and leads risk mitigation efforts and is responsible for the conduct of biological evaluations, chemical characterization, and toxicological risk assessmentsThis position plays a critical role in product development, ensuring patient safety while enabling early product development decisions, product design direction, product approvals, and market launch for product commercialization. MAJOR RESPONSIBILITIES Support and consult internal business partners with a good technical biocompatibility and toxicological background, with an understanding of relevant compliance standards to resolve issues and challenges. Author toxicological and/or biological assessments (Biocompatibility) for medical devices and/or cosmetic OTC products with regard to product design, design changes, manufacturing processes and post-production life-cycle activities for regulatory compliance. Prepares Biological evaluation plans and reports, in compliance with ISO 10993 and ISO 14971, for submissions to FDA, EU MDR, and other regulatory agencies. Remain current and apply the understanding of ISO 10993, ISO 14971, and regulatory agency guidance documents (e.g. FDA, EU MDR, PMDA, etc.) and pertinent quality system requirements. Develop and/or propose a regulatory strategy to support Biological evaluation plans to meet the project timeline and budget without jeopardizing the product safety. Write and/or review experimental protocols, test data, test reports, and overall assessment. Coordinate biocompatibility, extractable/leachable, or in-vivo safety testing required in support of a product claim Independent problem solver who can use a methodical approach to develop solutions and make recommendations. Represent Medline on various ASTM/AAM/ISO technical committees and contribute to the development of new test standards. Recommended Skills Assessments Biology Iso 14971 Manufacturing Medical Material Post Production Apply to this job. Think you're the perfect candidate? Apply on company site $(document).ready( function() $(#ads-desktop-placeholder).html(
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n Estimated Salary: $20 to $28 per hour based on qualifications.
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n Estimated Salary: $20 to $28 per hour based on qualifications.
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