Sr. Scientist, Toxicology (Board Certified) - Bracco Medical Technologies

Bracco•Eden Prairie, MN

3d•Hybrid

About The Position

The Sr. Scientist, Toxicologist will be responsible for providing leadership and support for biocompatibility and chemical characterization testing encompassing extractable and leachable analysis and evaluating the harmful effects of chemicals on Bracco Medical Technologies (BMT) products, determining the safe exposure levels, and ensuring compliance to BMT design control procedures and applicable regulations and external standards.

Requirements

Minimum Bachelor’s degree in Toxicology, Chemistry, Biology or other related technical / scientific background
10+ years of experience in Toxicology or a related field.
Board certified toxicologist (DABT or equivalent) is required.
Working knowledge of the FDA Quality System Regulation and EU Medical Device Regulations.
Experience performing toxicological risk assessments and biological evaluations in accordance with ISO 10993 and ISO 14971.
Knowledge of extractables and leachables (E&L) studies, analytical chemistry techniques, and interpretation of analytical data.
Moderate level of computer proficiency including MS Word, Excel, Project, and statistical applications software.
Effective oral and written communication skills.
Effective technical writing skills.
Ability to work independently and prioritize assignments to meet project timelines.

Nice To Haves

Masters degree plus 7 years in Toxicology or a related field, or PhD in Toxicology plus 3 years of experience in Toxicology or a related field.
Demonstrated knowledge of ISO 10993 series of standards.
Experience authoring Biological Evaluation Plans (BEPs), Biological Evaluation Reports (BERs), and supporting FDA, MDR, and other global regulatory submissions.
Experience managing external testing laboratories and collaborating with cross-functional teams throughout the medical device product lifecycle.

Responsibilities

Support biocompatibility and other chemical and toxicology testing for consumable devices to identify, understand, and assess the toxic effects of identified chemicals and substances on patients supported by BMT products.
Interpreting data from studies, drawing conclusions, and making recommendations for safety and regulatory compliance.
Advising on safe exposure levels for substances identified in BMT products.
Collaborating with project teams and testing facilities in the development of testing required for assessment of biocompatibility.
Providing expert advice in legal and regulatory matters related to toxicology.
Lead Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) in accordance with ISO 10993.
Conduct toxicological risk assessments supporting product development, design changes, supplier changes, and regulatory submissions.
Provide technical leadership for extractables and leachables (E&L) studies, including protocol development, data review, and report approval.
Partner with R&D, Design Assurance, Regulatory Affairs, and Supplier Quality to integrate biological safety throughout the product lifecycle.
Monitor emerging regulatory requirements and maintain internal biological safety procedures, standards, and best practices.