Biocompatibility Scientist

Biocompatibility Scientist

JOB-10045477

Anticipated Start Date

December 15, 2025

Location

Gainesville, FL

Type of Employment

Contract Hire

Employer Info

Our client develops, manufactures, markets, distributes, and sells orthopedic implant devices, related surgical instrumentation, and biologic services. Many of the roles are temp to hire with our client. All of their buildings are air-conditioned and a comfortable work environment.

Job Summary

T he Biocompatibility Scientist is responsible for developing biocompatibility evaluation strategies, overseeing biological safety projects, and generating objective evidence to support the biocompatibility of medical devices and materials in alignment with the ISO 10993 series of standards. This role applies deep technical expertise to support the full product lifecycle, ensure regulatory compliance, and provide guidance regarding the biological safety of materials and processes for new products, line extensions, and modifications to existing products.

Job Description

• Collaborate with cross-functional partners across Regulatory, Clinical Affairs, Quality Assurance, Research & Development, and Manufacturing Engineering to ensure timely completion of biological assessments for new product development and internally manufactured or externally supplied products.
• Assist in scheduling, planning, and directing biocompatibility project activities by applying appropriate resources to support New Product Development, Sustaining Engineering, and supplier change initiatives.
  
• Develop technical solutions to complex and unique biocompatibility challenges, ensuring that solutions are innovative and aligned with organizational objectives.
  
• Manage biological assessments for multiple concurrent projects, providing critical review and interpretation of data, and escalating project constraints to leadership when necessary.
  
• Facilitate laboratory testing activities, including but not limited to: chemical characterization studies, toxicological risk assessments, biological testing, and laboratory investigations.
  
• Review, interpret, and summarize testing data to ensure complete and accurate documentation. Prepare and coordinate internal and external documents such as Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs), leveraging existing resources where appropriate.
  
• Serve as a corporate Subject Matter Expert (SME) in biocompatibility, supporting regulatory submissions, interactions with regulatory bodies (e.g., FDA, BSI), and on-site assessments pertaining to biological safety compliance.
  
• Apply knowledge of Quality Systems and relevant federal and international standards applicable to medical device manufacturing and biological safety.

Skills Required

• Demonstrated experience with ISO 10993 standards and medical device biocompatibility.
• Strong understanding of chemical characterization, toxicological risk assessment, and biological test methods.
  
• Ability to interpret complex technical data and generate clear, concise documentation.
  
• Excellent organizational and project management skills, with the ability to manage multiple priorities.
  
• Strong interpersonal skills and experience collaborating with cross-functional teams.
  
• Knowledge of FDA, EU MDR, and international regulatory requirements related to biological safety.

Education

• Bachelor’s or Master’s degree in Biomedical Engineering, Materials Science, Toxicology, Chemistry, Biological Sciences, or a related technical field.
• Advanced degree (M.S. or Ph.D.) in a relevant scientific discipline is preferred

Additional Requirements

• Experience supporting regulatory submissions or interacting with regulatory bodies is preferred.
• Familiarity with Good Laboratory Practice (GLP) environments is preferred.
  
• Experience working within a medical device or related regulated industry is preferred.
  
• Prior experience serving as a biocompatibility SME within an organization is preferred.

Pay Rate

• $120 per hour and higher depending on experience

We are an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.