Remote: Biocompatibility Specialist (231148)

Life Sciences & Technology
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Job Description:

A Black Diamond client is seeking a Biocompatibility Specialist for a 6-12 month contract. The Biocompatibility Specialist will collaborate with associates of diverse technical backgrounds and partner with project team engineers, quality engineering, manufacturing, packaging, sterilization and regulatory Subject Matter Experts to achieve desired project outcomes.

Additional responsibilities include:

  • Compile/write biocompatibility strategies, evaluations, and process approval memos
  • Act as study sponsor for testing conducted at external testing laboratories, especially NVR/FTIR, ICP/MS, and cytotoxicity testing
  • Ensure all testing meets ISO, FDA, CDRH, and GLP requirements
  • Review engineering protocols and external lab protocols and reports for completeness and accuracy
  • Assess and document test results, primarily for NVR/FTIR, ICP/MS, and cytotoxicity testing
  • Execution of biological safety evaluations of medical devices according to ISO 10993, including gap assessment activities
  • Understand and identify possible gaps for ISO 10993-1 and supporting ISO 10993 testing where needed.
  • Work with site staff to locate and review existing product documentation in respect to device biocompatibility, manufacturing, packaging, and sterilization
  • Ensure documentation is accurate, consistent and on the current template revision

 

 

Required Experience:

  • Education: Master’s degree in toxicology, chemistry, biochemistry, biology or similar discipline preferred
  • Experience in medical device toxicology/biocompatibility work required
  • Experience in working with external testing laboratories preferred
  • Experience in drafting technical documentation with attention to detail strongly preferred
  • Excellent written and verbal communication skills (English) required
  • Proficient in managing and prioritizing multiple tasks required
  • Motivated team player with a problem-solving attitude required

 

 

Remote: Biocompatibility Specialist (231148)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote

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