Senior Med Device Toxicologist

Boston Scientific; George Town; On-site; MYR 35,000 - 55,000; Full time

Job summary

A leading global medical technology company seeks an expert in biocompatibility and toxicology. This position involves supporting product development and regulatory submissions, ensuring patient safety, conducting assessments, and educating teams on biocompatibility. Ideal candidates will have extensive experience and relevant educational background.

Qualifications

• 8+ years in medical device biocompatibility or equivalent experience preferred.
• Experience with regulated authorities is a plus.
• Excellent written and verbal communication skills in English.

Responsibilities

• Support biocompatibility processes and ensure data accuracy.
• Author and review Chemical Safety Assessments.
• Maintain communication on biocompatibility and toxicology issues.

Skills

Biocompatibility knowledge

Chemical Safety Assessments

Toxicology expertise

Communication skills

Education

Bachelor's or Master's in Toxicology, Chemistry, Biochemistry, Biology, Biomedical Science

Job description

Purpose Statement

Provides support for biocompatibility and toxicology processes and related technical support to assigned business divisions in support of new product development, regulatory submissions, and manufacturing and engineering changes to meet business objectives. Additionally, this position is responsible for conducting Chemical Safety Assessments to evaluate potential extractables, leachables, residuals, and assessing potential patient safety impacts related to these exposures.

Job Responsibilities

• Support biocompatibility processes initiated by department management, ensuring data accuracy, reliability, and alignment with Global Preclinical objectives and Quality Management System requirements.
• Demonstrate a primary commitment to patient safety and product quality.
• Author and review Chemical Safety Assessments and toxicology memos to support divisional objectives.
• Consult and advise biocompatibility specialists on test plan development, review and approve assessments and reports, and evaluate test data to support business needs.
• Maintain communication with internal customers on biocompatibility and toxicology issues, supporting problem-solving related to chemical risk assessments.
• Provide expertise on biocompatibility, chemistry, and toxicology testing during device development programs.
• Advise on regulatory requirements for medical device submissions and support corporate initiatives.
• Participate in biocompatibility training programs for device development teams based on standards and regulations.
• Serve as a resource for biocompatibility and toxicology information related to medical devices and pharmaceutical materials.
• Advise on procedures, techniques, concepts, and approaches used at divisional levels for biocompatibility and toxicology programs.

Job Requirements

• Bachelor's or Master's degree in Toxicology, Chemistry, Biochemistry, Biology, Biomedical Science, or related field.
• Excellent written and verbal communication skills in English.
• Understanding of principles, theories, and concepts in the biocompatibility of medical devices; ISO 10993 experience preferred.
• Results-oriented, detail-focused, capable of multitasking under tight deadlines.
• Adaptable to a dynamic environment, able to work independently and in teams.
• At least 8 years of medical device biocompatibility experience or an equivalent combination of education and experience preferred.
• Experience working with regulated authorities is preferable.

About Us

As a global medical technology leader for over 40 years, Boston Scientific (NYSE: BSX) is dedicated to transforming lives through innovative medical solutions that improve patient health. Join us to make a meaningful difference worldwide and locally.