Early Career Biocompatibility Toxicologist - Gradient (Job)
Description:
Essential Duties and Responsibilities
- Make important contributions to patient safety by supporting medical device products through regulatory submission.
- Willingness to learn Biological Safety regulations (ASTM, ISO, FDA and EN standards, and ISO 10993 and ISO 18562).
- Review toxicity study design and perform toxicological risk assessments assessment in compliance with ISO 10993 and ISO 18562.
- Review biocompatibility data and testing protocol for compliance with regulatory requirements.
- Ability to coordinate with external labs to communicate test methods, sample submission, and review of test lab reports.
Skills/Eligibility:
Education and Licensure
- Bachelor’s degree in Molecular/Cell Biology, Toxicology, Biomedical Engineering, Biochemistry, or other medical related discipline. (required)
- Advanced degree in Molecular/Cell Biology, Toxicology, Biomedical Engineering, Biochemistry, or other medical related discipline. (preferred)
Skills, Experience and Qualifications
- At least 2 years of applicable experience; or equivalent combination of education and experience. (preferred)
- Exceptional written and oral communication skills. (required)
- Excellent quantitative and organizational skills. (required)
- Solid knowledge of toxicology and understanding of the risk assessment process. (required)
- Ability to learn quickly and work independently in a challenging and fast-paced work environment. (required)
- Prior consulting or medical device experience. (preferred)
- Experience in medical device material selection and manufacturing processes to evaluate patient/product safety. (preferred)
- Strong data management experience. (preferred)