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Toxicologist, Senior

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Remote Global
Onsite Location(s): 

Kangnam-gu, KR

Scientist II – Medical Device Toxicologist

About This Role:

The Scientist II – Medical Device Toxicologist at Boston Scientific provides technical support for toxicology and biocompatibility processes to meet global business objectives. Additionally, this position is responsible for the biological evaluation of medical device products, including the conduct of toxicological risk assessments based on data derived from extractables and leachables studies, in support for new product development and sustaining activities, as well as in support of global regulatory submissions. Global Toxicology and Biocompatibility plays a critical role in medical device development, ensuring patient safety while enabling early product development decisions, product design direction, product approvals, and market launch for product commercialization. 

 

Your Responsibilities Will Include:

    Working closely with R&D, regulatory affairs, quality engineering, and manufacturing, maintain close communications with internal customers on the strategies for the biological evaluation of medical devices, including chemical characterization, biocompatibility testing, and toxicological risk assessment.

    Develop testing strategies, coordinate and monitor testing with external research labs, assess data, and author biological evaluation reports for assigned business divisions.

    Conduct toxicological risk assessments in conformance with established guidance (ISO 10993, ICH, etc.).

    Providing guidance and interpretation of regulatory requirements related to medical device submissions for assigned business divisions

    At the basis of every decision, demonstrates a primary commitment to patient safety and product quality.

 

What We’re Looking For:

Required Qualifications

    A PhD degree in Toxicology or related field (biology, chemistry, biochemistry, biomedical engineering), with 1+ years of related experience

    Knowledge of the biological evaluation of medical devices and / or drug-device combination products

    Excellent written and verbal communication skills

    Results and detail-oriented

    Able to multi-task while working against aggressive timelines

    Comfortable in a dynamic environment and able to work independently as well as on teams

 

 

 

Preferred Qualifications

    Applied knowledge and understanding of toxicology principles and best practices

    Working knowledge of risk assessment methodologies, including the toxicological evaluation of medical device materials.

    Working knowledge of regulatory standards and global regulatory requirements with respect to medical device and combination products.

    Experience with running GLP and nGLP studies

 

 

 

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Job Segment: Medical Device, Regulatory Affairs, Compliance, Research Scientist, Senior Quality Engineer, Healthcare, Legal, Science, Engineering

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