This position is responsible for working in a cross-functional team of scientists and engineers to serve as the subject matter expert for toxicology and biocompatibility for all of Teleflex Medical products. This role will primarily be responsible for supporting patient safety assessments through completing risk assessments, literature reviews, and assessing various biology and chemistry studies for various Teleflex Medical products to support product development activities and regulatory submissions.
- Review biological and chemical study reports to determine the course of action to complete biological evaluations and risk assessments.
- Independently author risk assessment documents in compliance with ISO 10993, MDR, and other regulatory requirements as needed.
- Provide support to the biocompatibility program and assure biocompatibility related information and data is accurate, reliable, and supports business objectives consistent with the department.
- Maintain a working knowledge of applicable external standards and regulatory requirements for the biological safety of medical devices and mentor the development of this knowledge to others.
- Maintain and execute the biocompatibility program/policy for Teleflex Medical to endure all products and processes comply with the relevant regulatory standards.
- Provide input to creating strategies to assure compliance to regulatory standards regarding biocompatibility for Teleflex Medical products.
- Ensure company documentation related to biocompatibilty are maintained and updated with most current regulations, standards, and industry practices.
- Perform miscellaneous projects and duties as assigned.
- Adhere to and ensure the compliance of Teleflex Medical Code of Conduct, all company policies, rules, procedures, and housekeeping standards.
Education / Experience Requirements
- PhD in Toxicology with strong skills in both biology and chemistry.
- 1+ years of experience in the medical device industry.
- Working knowledge of biocompatibility evaluations for medical device and drug-device combination products.
- Strong experience with toxicological assessments of extractables and leachables of medical device materials.
- DABT Certification is desired, however those eligible to sit for the exam will also be considered
Specialized Skills / Other Requirements
- Strong communication and technical writing skills
- Biocompatibility Evaluation and Testing Standards Knowledge (ISO 10993, ISO 18562, MDR 2017/745, GB/T 16886, FDA Guidance 1811, etc.)
- MS Office Experience (Word, Excel, Access, PowerPoint)
- Strong problem solving skills
- Ability to communicate and operate effectively with cross functional teams.
- Adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts