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Staff Toxicologist - Quality Labs (can be remote-based in the US)

Company: Edwards Lifesciences Corp
Location: Raleigh
Posted on: June 12, 2021

Job Description:

This position is eligible for full relocation OR can be remote-based in the US

The Edwards Quality Labs provides a comprehensive range of testing and consulting services for safety and biocompatibility in order to support clinical product development including new product development, manufacturing support, and life cycle management for Edwards Lifesciences' medical devices.

The Staff Toxicologist will participate in the development and implementation of biological safety test strategies and conducting toxicological risk assessments to support biological evaluation of Edwards Lifesciences medical devices. We are looking for a Toxicologist with a commitment to patient safety and product quality, who enjoys being hands on, working in a fast paced environment, and able to effectively collaborate with colleagues located worldwide.

Key Responsibilities:

  • Provide input into the development and implementation of ISO10993 biological safety test strategies

  • Assess test data and write and approve Toxicological/Biocompatibility Assessments and Reports

  • Maintain communications with internal customers on biocompatibility issues, support problem solving related to chemical risk assessments

  • Work with product development, lab personnel and management on risk assessment findings

  • Supports the provision of guidance and interpretation of regulatory requirements related to medical device submissions for all Edwards business units

  • Collaborate as a part of cross functional teams including Regulatory Affairs partners to ensure business unit project timelines are met

  • Compilation of regulatory data packages to FDA/other relevant notified bodies and authorities globally.

  • Development of technical review documents including risk assessments and toxicological data summaries.

  • Support addressing biocompatibility questions from regulatory agencies and notified bodies

  • This position serves as a major resource for biosafety and toxicology information for medical devices which may include issues related to colorant additives, solvents, metals, and other hazardous chemicals

Education and Minimum Requirements:

MS in scientific discipline with 6+ years of relevant toxicology experience in the medical device or life science industry; or PhD in scientific discipline with 3+ years relevant toxicology experience in the medical device or life science industry.

Preferred Qualifications:

  • Toxicology experience for class III cardiovascular devices
  • DABT certification

Additional Talents and General Expectations:

  • Scientific and technical writing skills
  • Proven successful project management and leadership skills
  • Proven expertise in MS Office Suite
  • Excellent facilitation and presentation skills
  • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
  • Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
  • Extensive knowledge and understanding of Edwards policies and procedures relevant to biology
  • Extensive knowledge and understanding of biology principles, theories and concepts
  • Full knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, GLP)
  • Excellent written and verbal communications skills
  • Advanced problem-solving skills
  • Ability to manage confidential information with discretion
  • Strong leadership skills and ability to influence change
  • Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment
  • Ability to work in a team environment, including frequent inter-organizational and outside customer contacts

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Keywords: Edwards Lifesciences Corp, Raleigh , Staff Toxicologist - Quality Labs (can be remote-based in the US), Other , Raleigh, North Carolina

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