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Senior Toxicologist Job

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Date: Dec 1, 2018

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Location: Marlborough, Massachusetts (US-MA), United States (US)
Additional Locations: US-IN-Spencer; US-MN-Arden Hills; US-MN-Maple Grove; US-MN-Minnetonka

 

 

About this role:

The Senior Toxicologist provides support for the biocompatibility processes and related technical support to all of Boston Scientific Corporation, in support of new product development, regulatory submissions and manufacturing and engineering changes to meet business objectives. Additionally, this position is responsible for conducting toxicological risk assessments to support biological evaluation of medical devices.

 

Your responsibilities will include: 

  • The Senior Toxicologist will support the biocompatibility systems initiated by the department management and assure biosafety-related information and data is accurate, reliable, and supports business objectives as consistent with the Global Toxicology/Biocompatibility Organization objectives.
  • Demonstrate a primary commitment to patient safety and product quality.
  • Provide input to testing strategy, write and approve Biocompatibility Assessments and Reports and assess test data
  • Maintain communications with internal customers on biocompatibility issues, support problem solving related to chemical risk assessments.
  • Provide guidance of testing related to new investigational and strategic device development programs
  • Provide guidance and interpretation of regulatory requirements related to medical device submissions for all divisions
  • Aid in the development and implementation of a Biocompatibility Training Program for all functional groups of device development teams based on standards and regulatory requirements
  • Act as the primary liaison to the Contract Research Organizations for biocompatibility and toxicology testing
  • This position serves as a major resource for biosafety and toxicology information for medical devices and pharmaceutical materials, which may include issues related to colorant additives, solvents, metals, and other hazardous chemicals
  • Additionally, the position directly influences procedures, techniques, concepts and approaches used at divisional levels for biosafety programs.
  • This position will consult on biocompatibility and toxicological issues, support problem solving and resolution

 

 

What we’re looking for in you:

Minimum Qualifications

  • MS or PhD degree in Toxicology
  • 3+ years of toxicology experience in the medical device industry
  • Working knowledge of biocompatibility evaluations (ISO 10993-1) for medical devices and drug-device combination products
  • Experience with toxicology assessments of leachable and extractable of medical device materials
  • Applied knowledge and understanding of toxicology principles and best practices, regulatory standards, and requirements in the context of business activities

Preferred Qualifications

  • DABT certification is a plus
  • Communication and presentation skills, action oriented, self-starting, program development and project management experience
  • Scientific and technical writing and leadership skills

 

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 437356

 


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