Medical Device Toxicologist
Gradient, an environmental consulting firm is seeking a driven, high energy individual to assist colleagues and clients in toxicological risk assessments and biological safety evaluations for medical devices. Excellent benefits, friendly, hybrid work environment with a great location in downtown Boston.
Applicants should possess the following:
• Willingness to learn Biological Safety regulations (ISO 10993 and ISO 18562) and geography-specific requirements for both the USA and European Union to support regulatory submissions.
• Review and analyze technical data from multiple sources to assess potential toxicological risks and compliance to current regulations.
• Ability to conduct strategic biological safety evaluation programs for medical devices that include: hazard identification, literature reviews, use of new and existing biological safety data, design of chemical characterization studies for extractables and leachables, and toxicological risk assessments.
• Ability to coordinate with external labs to communicate test methods, sample submission, and review of test lab reports.
• Experienced in medical device material selection and manufacturing processes to evaluate patient/product safety is a plus.
Experience and Skills:
Position requires at least an M.S. in toxicology or related field. Candidates must have excellent writing and quantitative skills, and the ability to work independently in a challenging and fast-paced work environment. Prior consulting or industry experience in medical device field, including managing projects with multiple staff is a plus. Strong data management experience is a plus.
Our Benefits are Comprehensive and Include:
Medical and dental insurance
Disability insurance (short- and long-term)
Paid time off (holidays, vacation, and sick leave)
Professional development allowances
Company-wide bonus program
Company-paid public transportation options
Professional registration fee reimbursement
Gradient provides employees with the right tools to meet challenges and to excel and grow both personally and professionally.