Responsibilities
- Possess in depth understanding of 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.
- 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.
- Coordinate with external labs to communicate test methods, sample submission, and review of test lab reports.
- Manage projects related to biomedical toxicological risk assessment and/or biocompatibility related projects.
Requirements
- Bachelor’s degree in toxicology or related field
- at least 8 years (10+ preferred) in the field of medical device or pharmaceutical biocompatibility; or equivalent combination of education and experience
- Exceptional written and oral communication
- Excellent quantitative skills
- The ability to work independently in a challenging and fast-paced work environment
Nice to Have
- Advanced degree in toxicology or related field
- Prior consulting or industry experience in medical device or pharmaceutical field, including managing projects with multiple staff
- Strong data management experience
- Experienced in medical device material selection and manufacturing processes to evaluate patient/product safety
Benefits
- competitive pay and benefits
- well-being programs to support you and your family
- 9 paid holidays
- 2 floating holidays
- a minimum of 8 sick days
- a minimum of 11 vacation days per year
- medical, dental, vision, life, and disability insurance
- 401(k)
- a variety of leaves of absences
Work Arrangement
Remote (City/Region)
Additional Information
- This opportunity will be posted for at least five days.
