Senior Med Device Toxicologist

Boston Scientific Gruppe; Penang; On-site; MYR 50,000 - 100,000; Full time

Job summary

An established industry player in medical technology seeks a dedicated professional to support biocompatibility and toxicology processes. This role involves conducting Chemical Safety Assessments, ensuring patient safety, and providing technical expertise during new product development. You'll collaborate with various teams to maintain high standards of quality and regulatory compliance. If you have a passion for improving patient health and possess extensive experience in biocompatibility, this opportunity is your chance to make a significant impact in the healthcare sector.

Qualifications

• 8+ years of experience in medical device biocompatibility or related field.
• Strong understanding of ISO 10993 and medical device regulations.

Responsibilities

• Support biocompatibility processes ensuring data accuracy and alignment with objectives.
• Author and review Chemical Safety Assessments and toxicology memos.

Skills

Biocompatibility

Toxicology

Chemical Safety Assessments

Regulatory Consultation

Communication Skills

Education

Bachelor’s or Master’s degree in Toxicology

Degree in Chemistry, Biochemistry, Biology, Biomedical Science

Job description

Provides support for biocompatibility and toxicology processes, offering technical support to assigned business divisions to aid in new product development, regulatory submissions, and manufacturing changes. Additionally, this role conducts Chemical Safety Assessments to evaluate potential extractables, leachables, residuals, and patient safety impacts related to these exposures.

Job Responsibilities:

1. Support biocompatibility processes initiated by department management, ensuring data accuracy, reliability, and alignment with Global Preclinical objectives and Quality Management System requirements.
2. Demonstrate a primary commitment to patient safety and product quality.
3. Author and review Chemical Safety Assessments and toxicology memos to support divisional objectives.
4. Consult and advise biocompatibility specialists on test plans, review and approve assessments and reports, and evaluate test data to support business needs.
5. Maintain communication with internal customers regarding biocompatibility and toxicology issues, supporting problem solving related to chemical risk assessments.
6. Provide expertise on biocompatibility, chemistry, and toxicology testing during new device development programs.
7. Offer regulatory consultation for medical device submissions and support corporate initiatives.
8. Participate in Biocompatibility Training programs for device development teams based on standards and regulatory requirements.
9. Serve as a resource on biocompatibility and toxicology issues, including materials of animal origin, colorant additives, and chemical exposure assessments.
10. Advise on procedures and techniques used at divisional levels for biocompatibility and toxicology programs.

Job Requirements:

1. Bachelor’s or Master’s degree in Toxicology, Chemistry, Biochemistry, Biology, Biomedical Science, or related field.
2. Excellent written and verbal communication skills in English.
3. Understanding of principles and concepts in medical device biocompatibility; ISO 10993 experience preferred.
4. Results-oriented with attention to detail; capable of managing multiple tasks under tight timelines.
5. Ability to work independently and collaboratively in a dynamic environment.
6. At least 8 years of experience in medical device biocompatibility or an equivalent combination of education and experience.
7. Experience with regulated authorities is preferred.

About Us:

Boston Scientific is a global medical technology leader with over 40 years of experience, dedicated to transforming lives through innovative medical solutions that improve patient health. Join us to make a meaningful difference worldwide.