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Featured Employers
Director Biocompatibility and Toxicology
Company: Cardinal Health
Location: Waukegan, IL
Employment Type: Full Time
Date Posted: 10/21/2020
Expire Date: 12/29/2020
Job Categories: Healthcare, Practitioner and Technician, Science, Executive Management, Quality Control, Research & Development, Writing/Authoring
Job Description
Director Biocompatibility and Toxicology

Reporting to the Vice President, Regulatory Affairs, the Director will oversee the Biocompatibility and Toxicology program for the Medical Solutions Business, supervise the team of scientists and support staff, and collaborate effectively with team members from various disciplines globally to develop biocompatibility evaluation strategies and objective evidence to support biocompatibility of medical device products according to the ISO 10993 standard series and global regulatory agency requirements.

Qualifications

  • Ph.D. in Toxicology or relevant field; DABT certification required
  • 10 plus years of experience in medical device industry or biocompatibility research organization working on biocompatibility of medical devices.
  • Demonstrated leadership, coaching and development of personnel in diverse and inclusive teams.
  • Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities and develop effective and efficient programs or processes to manage ensuing workload for self and team.
  • Strong interpersonal skills with an ability to develop solid, long-term relationships and to work effectively in a team setting/matrix-type organization
  • Deep working knowledge of ISO 10993 standards for biocompatibility, a strong background in regulatory toxicology including extensive knowledge and understanding of Good Laboratory Practices.
  • Proven track record of conducting medical device safety assessment studies, demonstrated ability to manage multiple scientific projects and make sound scientific interpretations and risk assessments.
  • Authorship on biocompatibility/toxicology in peer reviewed publications.
  • Experience coordinating work through outside service laboratories (e.g. extractables/leachable testing and non-clinical safety studies)
  • Experience with sample preparation/extraction/ separation techniques for material analyses, polymers and analytical chemistry, and instrumentation analysis e.g. FTIR, HPLC, GC, IC, ICP-MS, GC/MS spectroscopic techniques
  • Experience reading, analyzing, and interpreting common scientific and technical journals/literature, scientific procedures and regulatory guidelines and writing technical reports, toxicological risk assessment or biocompatibility evaluations
  • Experience working in a Design Control environment in a Quality Management System.
  • Attention to detail and critical thinking skills to Interpret available data and recommend strategies to resolve technical challenges.
  • Strong oral and written communication skills

What is expected of you and others at this level

  • Provides leadership to managers and experienced professional staff may also manage front line supervisors
  • Manages an organizational budget
  • Develops and implements policies and procedures to achieve organizational goals
  • Assists in the development of functional strategy
  • Decisions have an extended impact on work processes, outcomes, and customers
  • Interacts with internal and/or external leaders, including senior management
  • Persuades others into agreement in sensitive situations while maintaining positive relationships

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

Contact Information
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