Job Description
Job Summary
Serve as a subject matter expert, providing strategic guidance and scientific expertise to cross-functional teams, including R&D, quality, and regulatory affairs. This senior-level position requires deep expertise in toxicology, a strong understanding of international regulations, and excellent leadership skills. This position ensures product safety and leads risk mitigation efforts in the form of biological evaluations, chemical characterization, and toxicological risk assessments for medical devices, OTC, and cosmetic products. The role involves guiding product development teams and mentoring junior staff to ensure patient safety and product quality.
Responsibilities: - Provide strategic input for regulatory submissions (e.g., 510(k), CE marking, PMDA) and interact with global regulatory bodies.
- Risk Assessment and Evaluation: Conduct and lead toxicological risk assessments for new and existing medical devices, components, and materials. This includes creating Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) in accordance with ISO 10993 and responding to questions from regulatory agencies.
- Develop and implement strategies for biological evaluation to ensure compliance with global regulatory standards, such as those from the FDA and EU MDR.
- Stay current with emerging trends and advancements in the field of toxicology and product safety and integrate predictive toxicology tools into safety assessments.
- Mentor and guide junior toxicologists and scientists, fostering technical growth and knowledge sharing.
- Conduct and interpret chemical characterization (e.g., E&L studies, ISO [click to reveal phone number]10993-18 , ISO 18562), SAR/QSAR modeling, and guide biocompatibility testing under GLP requirements.
- Serve as a subject matter expert, providing strategic guidance and scientific expertise to cross-functional teams, including R&D, quality, and regulatory affairs. Advise on potential risks and hazards associated with product materials and processes.
- Independent problem solver who can use a methodical approach to develop solutions and make recommendations.
- Represent the organization in external forums, regulatory meetings, and industry working groups (e.g., ASTM, ISO).
Qualifications:
- Bachelor's degree in Toxicology, Pharmacology, or a related scientific field
- 10+ years of experience in toxicology, with a significant focus on medical devices or a closely related industry (e.g., pharmaceutical, biotech) and toxicological risk assessments, biocompatibility assessments, and chemical characterization.
- In-depth 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), leadership, and problem-solving skills. The ability to manage multiple projects simultaneously and work effectively in a matrixed environment is critical.
Preferred Qualifications:
- 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.
- 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.
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:
$152,880.00 - $229,320.00 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 a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
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.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Job Tags
Minimum wage, Full time, Local area, Worldwide,