Biological Safety Coordinator

1 month ago

Brooklyn Park, Minnesota, United States Olympus Corporation of the Americas Full time

Working Location: MINNESOTA, BROOKLYN PARK

Workplace Flexibility: Hybrid

For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. __

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus ) .

**Please note: All correspondence will be sent from our Olympus domain ). If you receive correspondence from an entity other than , it is likely not legitimate.

Job Description

This position is responsible for providing Biological Safety support and expertise to the Olympus Surgical Technologies America group and ensuring that the coordination of biocompatibility related Operational activities are in compliance with internal and external requirements and regulations. The Biological Safety Coordinator will assist with medical device evaluations for safety per the ISO 10993 series and will execute testing and reporting for new product development and existing product.

Job Duties

  • Supports the evaluation of medical devices for safety per the ISO 10993 series.
  • Manage outsourced contract research (GLP- and non-GLP) performed by external laboratories.
  • Coordinate biocompatibility testing between internal stakeholders and external laboratories for new and existing products.
  • Determine sample requirements for biocompatibility testing per ISO 10993 guidelines and laboratory testing specifications.
  • Develop sample preparation instructions for biocompatibility testing.
  • Review toxicological and biocompatibility results and document in reports.
  • Collaborate with cross functional teams to evaluate manufacturing, material, and product changes for their impact on biological safety.
  • Assist with root cause investigation for issues associated with biocompatibility testing.
  • Liaison support of external laboratories for the companies' biocompatibility and toxicological aspects of regulatory submissions.
  • Train biological safety team members on the use of internal electronic management systems and documentation practices.

Job Qualifications

Required:

  • Bachelor's degree in Science/Engineering/Biomedical required. MS or higher degree in biochemistry, toxicology or similar discipline preferred.
  • Minimum of 3 years of experience with biocompatibility requirements within an FDA regulated medical device environment.
  • Strong Knowledge of ISO 10993 and FDA's Biological Evaluation Guidance.
  • Scientific analytical and writing skills.
  • Good communication skills and writing skills.
  • Familiarity with pertinent FDA, EUMDR, AAMI, OSHA and ASTM regulations and guidelines.
  • Travel:

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