Job SummaryServe as a subject matter expert, providing strategic guidance and scientific expertise to cross-functional teams, including R&D, quality, and regulatory affairs. This position is responsible for toxicological risk assessments and biological evaluations of medical devices, OTC, and cosmetic products in support of new and sustaining product development activities, as well as global regulatory submissions. This position ensures product safety and supports risk mitigation efforts in the form of biological evaluations, chemical characterization, and toxicological risk assessments. This position plays an important role in product development by helping ensure patient safety while supporting product design, regulatory compliance, and commercialization activities.
Job DescriptionResponsibilities:- Provide strategic input for regulatory submissions (e.g., 510(k), CE marking, PMDA) and interact with global regulatory bodies.
- Author toxicological and/or biological assessments (Biocompatibility) for new and existing medical devices and/or cosmetic OTC products with their components and materials.
- Develop and implement strategies for biological evaluation to ensure compliance with global regulatory standards such as ISO 10993 and ISO 14971, for submissions to the FDA and EU MDR.
- Remain current and apply understanding of ISO 10993, ISO 18562, ISO 14971, FDA guidance, EU MDR, and other global regulatory guidance documents and pertinent quality system requirements.
- Review test protocols, test data, test reports, and overall technical assessments and interpret biocompatibility, chemical characterization, extractables/leachables, or in vivo safety testing result to support product safety claims and regulatory submissions.
- Conduct and interpret chemical characterization (e.g., E&L studies, ISO 10993-18, ISO 18562), SAR/QSAR modeling, and guide biocompatibility testing under GLP requirements.
- Serve as a technical resource to cross-functional teams including R&D, quality, and regulatory affairs, and advise on potential risks associated with product materials and processes.
- Independent problem solver who can use a methodical approach to develop solutions and make recommendations.
- Contribute to continuous improvement of toxicology and biocompatibility processes, tools, and documentation practices.
Qualifications:Education and Experience- Bachelor's degree in Toxicology, Pharmacology, or a related scientific field
Work Experience- 5+ years of experience in toxicology, with a significant focus on the medical device or a closely related industry (e.g., pharmaceutical, biotech) and toxicological risk assessments, biocompatibility assessments, and chemical characterization.
Knowledge / Skills / Abilities- Knowledge of toxicology principles, risk assessment methodologies, and global regulations like ISO 10993, ISO 18562, ISO 14971, FDA, and EU MDR.
- Must possess excellent communication (written and verbal), and problem-solving skills with the ability to manage multiple projects simultaneously and work effectively.
Preferred Qualifications:Work Experience- A Diplomate of the American Board of Toxicology (DABT) or equivalent certification is highly desirable.
- 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 manage multiple projects in cross functional teams.
- Comfortable in a dynamic environment and able to work independently as well as on teams.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$101,000.00 - $152,000.00 Annual
The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.
We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.
