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Medical Device Toxicologist II at Boston Scientific Corporation Malaysia
Arden Hills, Minnesota, United States -
Full Time

Start Date

Immediate

Expiry Date

05 Feb, 26

Salary

0.0

Posted On

07 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Biocompatibility, Toxicology, Regulatory Requirements, Device Development, Communication Skills, Multi-tasking, Dynamic Environment, Risk Assessment, GLP Studies, ISO 10993-1, Chemistry Testing, Biomedical Engineering, Detail-oriented, Independent Work, Team Collaboration

Industry

Medical Equipment Manufacturing

Description
Your responsibilities will include: Provide support for biocompatibility processes initiated by department management and ensure biocompatibility and toxicology related information and data are accurate, reliable, and support business objectives as consistent with Global Preclinical objectives and Quality Management System requirements. Provides input on the regulatory requirements related to medical device submissions, on procedures, techniques, concepts and approaches used at divisional levels for biocompatibility and toxicology programs. Participates as assigned in training for functional groups of device development teams based on standards and regulatory requirements. Provides input on biocompatibility, chemistry and toxicology testing related to new investigational and strategic device development programs. A BS / MS degree in Toxicology is preferred, or closely related field (biology, chemistry, biochemistry, biomedical engineering). 2+ years' experience supporting medical devices. 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. Knowledge of the biological evaluation of medical devices (ISO 10993-1) preferred. 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. Experience with running GLP and non-GLP studies. A BS / MS degree in Toxicology is preferred
Responsibilities
Provide support for biocompatibility processes and ensure data accuracy to support business objectives. Participate in training and provide input on biocompatibility and toxicology testing for new device development programs.