at Medline Industries, Inc. in Northfield, Illinois, United States
Job Description
Job Summary
Job Description
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.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.
Qualifications:
- 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 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 Qualifications:
- 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...
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
