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Principal Toxicologist - remote
Location:
Northfield, IL
Description:
JOB SUMMARY Serve as Subject Matter Expert for internal business partners and product development teams by providing technical expertise for toxicological and biocompatibility processes. This 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 submissions. This position ensures product safety and leads risk mitigation efforts and is responsible for the conduct of biological evaluations, chemical characterization, and toxicological risk assessments. This 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.Remote opportunity, which will require periodic travel to Northfield, IL corporate headquarters on a business need basis. 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. The anticipated salary range for this position is $130,000 - $229,320 annually. This salary range is an estimate and the actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus eligible. Medline will not pay less than the applicable minimum wage or salary threshold. MINIMUM JOB REQUIREMENTS COVID-19 Vaccination Please be aware thatMedlinerequires allemployees starting in thisposition to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date.Medlineis an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law. Education Bachelor's degree in Chemistry, Biochemistry, Biology, toxicology, or related science field. Work Experience 10 years industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility and toxicology. Knowledge / Skills / Abilities Knowledge of FDA requirements and experience with FDA interactions as part of the 510k approval processes Knowledge of CE technical files Working knowledge of FDA and EU MDR and other global medical device regulations and/or biologics regulations, ISO 10993, and 14971. PREFERRED JOB REQUIREMENTS Active Diplomate of the American Board of Toxicology (DABT) certification Experience and Knowledge of ISO 18562. Experience in chemical characterization risk assessment (10993-18). Experience and knowledge of pharmaceutical related field. Experience of quality audit by external regulatory bodies (FDA, EU Regulatory body, etc.). Experience in solving practical problems and dealing with a variety of concrete variables in situations where only limited standardization exists. Experience communicating with internal and external business partners and cross functional teams with various audiences. Knowledge / Skills / Abilities Must be team oriented, with the ability to work well on common deliverables with diverse cross-functional teams and to interact at the highest professional manner with excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site. Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical and problem solving skills. Strong time management skills to prioritize, organize track details and meet deadlines for multiple projects with varying completion dates. Ability to influence and motivate others to drive results in a multi-location and matrixed environment. Ability to manage multiple projects in cross functional teams. Comfortable in a dynamic environment and able to work independently as well as on teams.
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More About this Listing: Principal Toxicologist - remote
Principal Toxicologist - remote is a Other Jobs Principal Toxicologist Job at Medline located in Northfield IL. Find other listings like Principal Toxicologist - remote by searching Oodle for Other Jobs Principal Toxicologist Jobs.
Principal Toxicologist - remote is a Other Jobs Principal Toxicologist Job at Medline located in Northfield IL. Find other listings like Principal Toxicologist - remote by searching Oodle for Other Jobs Principal Toxicologist Jobs.