Senior Toxicologist - Simpang Ampat, Malaysia - Haemonetics

    Haemonetics
    Haemonetics Simpang Ampat, Malaysia

    2 weeks ago

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    Full time
    Description

    We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

    Job Details

    Responsibilities

  • Develops biological safety evaluation strategies, implementing a tiered risk-based approach to establish ISO 10993 compliance in support of new product development and registration.
  • Plans and manages the impact assessment of manufacturing, supplier, material and sterilization changes to medical devices with patient contacting components to ensure biological safety and product sustainability.
  • Review, interpret, and summarize raw data from Contract Research Organization reports and documents biological assessments using sound scientific principles.
  • Ensure that testing meets all international & domestic test requirements according to ISO, FDA, EU MDR, and GLP.
  • Conduct quantitative risk assessments on chemical characterization profiles as a part of biocompatibility evaluations.
  • Apply technical expertise to solve complex biocompatibility problems as related to the ISO 10993 standards and regulatory authority requirements for product safety.
  • Interact closely with and provide consultative direction to Quality, R&D, Clinical, and Regulatory Affairs within Haemonetics.
  • Support on-site and off-site Regulatory Authority audits to for product that may be sold in worldwide markets.

    • Requirement

  • 5+ years of experience with a Bachelor's degree, 3+ years of experience with an MS degree or 1+ years' experience with a PhD.
  • Experience in years as specified above in conducting toxicological risk assessments, designing and performing toxicological assays, and/or overseeing biological safety assessments.
  • Bachelor's degree in Toxicology, Biology, Chemistry, Engineering or related degree.
  • Functional expert in the principles Biocompatibility and Toxicological Risk assessment of disposable medical devices.
  • Knowledge of applicable ASTM, ISO, FDA, and EN standards with an in-depth understanding of ISO 10993 biocompatibility standards.
  • Knowledge of pertinent sections of REACH, the EU MDR, and Proposition 65 (hazardous substances regulations) as well as ICH and FDA Guidance Documents (, Threshold of Toxicological Concern and Use of ISO

    • EEO Policy Statement