Senior Toxicologist

Primary Function of Position

The Senior Toxicologist plays a key role in ensuring the biocompatibility and safety of medical devices materials and processes in compliance with global regulatory standards (ISO 10993 FDA EU MDR). This position is responsible for conducting toxicological risk assessments developing safety strategies and supporting regulatory submissions. The individual will work collaboratively with crossfunctional teams including engineering quality regulatory and clinical teams to evaluate and mitigate potential toxicological risks associated with medical device materials and components. Specific emphasis will be placed on candidates with proven experience supporting Class III medical devices.

Essential Job Duties

• Conduct and oversee toxicological risk assessments for medical devices and materials to ensure compliance with ISO 10993 standards and global regulatory requirements.
• Lead biocompatibility and chemical characterization studies collaborating with contract research organizations (CROs) to design plan and interpret toxicological testing.
• Evaluate potential toxicological hazards of new materials manufacturing processes and device modifications.
• Provide guidance on material selection ensuring the use of safe and biocompatible materials in product development.
• Support regulatory submissions by preparing toxicological safety assessments and responding to regulatory inquiries.
• Stay abreast of emerging toxicological methodologies computational toxicology models and regulatory updates to improve risk assessment approaches.
• Act as a subject matter expert and mentor within the organization educating internal teams on toxicological and biocompatibility considerations.
• Collaborate with engineering supplier quality and manufacturing teams to ensure toxicological compliance from design to commercialization for class III medical devices.
• Participate in scientific conferences regulatory meetings and industry working groups to contribute to the advancement of toxicology practices in the medical device industry.

Qualifications :

Required Skills and Experience

• Extensive experience in toxicological risk assessment and medical device safety evaluations.
• Strong knowledge of biocompatibility testing methodologies and regulatory frameworks (ISO 10993 FDA EU MDR etc..
• Demonstrated expertise in designing conducting and interpreting toxicology and biocompatibility studies.
• Proven ability to work crossfunctionally and effectively communicate toxicological findings to technical and nontechnical audiences.
• Experience working with regulatory bodies and preparing toxicologyrelated regulatory documentation for Class III devices.
• Strong analytical and problemsolving skills with attention to detail and scientific rigor. Excellent written and verbal communication skills.

Required Education and Training

• Masters degree in Toxicology Biomedical Science or a related field with 5 years of experience in toxicological risk assessment and biocompatibility evaluation preferably in the medical device industry.

OR

• Ph.D. in Toxicology Biomedical Science or a related field with 2 years of experience in the same areas.
• Board certification (e.g. DABT) is highly preferred.

Working Conditions

• Onsite role based in Sunnyvale CA.
• May involve occasional travel (up to 2 for regulatory meetings conferences or external collaborations.

Preferred Skills and Experience

• Experience with computational toxicology and in silico modeling.
• Expertise in extractables and leachables (E&L) assessments for Class III devices.
• Familiarity with Good Laboratory Practices (GLP) and regulatory compliance strategies.
• Knowledge of advanced analytical techniques (e.g. mass spectrometry chromatography) for chemical characterization.
• Experience with engaging directly with regulatory authorities for toxicological discussions.
• Strong project management skills with the ability to lead multiple initiatives simultaneously.

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Remote Work :

No

Employment Type :

Fulltime