Biological Safety Specialist

Posted 5ds ago

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Job Description

Biological Safety Specialist ensuring compliance with medical device regulations. Developing safety documents and auditing biocompatibility results according to regulatory standards.

Responsibilities:

  • Develop and maintain biological safety documents and reports
  • Assess/audit compliance of biocompatibility and material characterization results to applicable standards
  • Collaborate with teams for regulatory compliance and safety standards

Requirements:

  • Bachelor’s degree or equivalent experience in a related field
  • Master’s or Doctorate degree or equivalent experience in a related field, and a minimum of 2 years of relevant experience.
  • Fluency in English and local language, if different, required.
  • Knowledge and experience with applicable standards and regulations for medical devices
  • Ability to assess/audit compliance of biocompatibility and material characterization results to applicable standards and regulations.
  • Ability to develop biological safety documents and reports that are compliant with applicable standards and regulations.
  • Knowledge of and experience with Microsoft Word
  • Write and review complex documents