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Biocompatibility Manager Jobs in Missouri (NOW HIRING)

Oversee capacity planning, resource allocation, and performance management within the biocompatibility organization. * Ensure compliance with ISO 10993 and applicable global regulatory guidance.

Biocompatibility Manager information

What are the key skills and qualifications needed to thrive as a biocompatibility manager?

To thrive as a Biocompatibility Manager, you need expertise in toxicology, materials science, and regulatory standards, typically supported by a degree in a life science field and experience with medical device biocompatibility testing. Familiarity with ISO 10993 standards, risk assessment tools, and regulatory submission systems is essential. Strong analytical thinking, attention to detail, and effective communication skills help in collaborating with cross-functional teams and ensuring regulatory compliance. These skills and qualities are vital for ensuring product safety, regulatory approval, and successful market entry for medical devices.

What are the common challenges a biocompatibility manager faces when coordinating cross-functional teams during product development?

A Biocompatibility Manager often encounters challenges in aligning the priorities and timelines of various teams such as R&D, regulatory affairs, and quality assurance. Ensuring clear communication about testing requirements and regulatory updates is vital, as misunderstandings can lead to delays or non-compliance issues. Additionally, the manager must balance thorough risk assessments with project deadlines, all while staying current with evolving international standards. Effective collaboration and proactive problem-solving are key to overcoming these challenges and ensuring the safety and compliance of medical devices.

What does a biocompatibility manager do?

A Biocompatibility Manager oversees the evaluation and testing of medical devices and materials to ensure they are safe and compatible with human tissues. Their responsibilities include designing testing protocols, interpreting regulatory requirements, and ensuring compliance with international standards like ISO 10993. They work closely with research, development, and regulatory teams to address any risks related to biological safety. Their work is critical for gaining regulatory approvals and ensuring patient safety.

What is the difference between Biocompatibility Manager vs Biocompatibility Specialist?

AspectBiocompatibility ManagerBiocompatibility Specialist
CredentialsTypically requires a degree in life sciences or biomedical engineering; certifications like ISO 10993 are commonSimilar educational background; often holds certifications in biocompatibility testing
Work EnvironmentOversees teams, manages projects, and ensures compliance across departmentsPerforms testing, data analysis, and reports within labs or R&D settings
Industry UsageUsed in regulatory, quality assurance, and management roles within medical device companiesPrimarily involved in testing and technical analysis within laboratories

The main difference is that the Biocompatibility Manager oversees testing programs and compliance strategies, while the Biocompatibility Specialist focuses on conducting tests and technical analysis. Both roles require similar credentials but differ in scope and responsibilities.

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Infographic showing various Biocompatibility Manager job openings in Missouri as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Director, Biocompatibility

Jobtailor

California, MO • On-site

$180 - $240/hr

Other

Posted 6 days ago


Job description

Responsibilities
  • Develop and execute the global biocompatibility strategy aligned with business and regulatory objectives.
  • Provide scientific and regulatory leadership on biological safety and toxicological risk assessment for materials, manufacturing processes, and finished products.
  • Integrate biocompatibility considerations early in product design, development, and lifecycle management.
  • Lead and mentor teams of biocompatibility scientists across multiple sites.
  • Foster a culture of collaboration, accountability, and continuous improvement.
  • Oversee capacity planning, resource allocation, and performance management within the biocompatibility organization.
  • Ensure compliance with ISO 10993 and applicable global regulatory guidance.
  • Provide expert input for regulatory submissions (IDE, PMA, 510(k), CE, NMPA, etc.) and represent the function during audits and agency interactions.
  • Maintain strong awareness of evolving global biocompatibility and toxicology regulations and guide the organization in adapting accordingly.
  • Oversee biological evaluation plans, toxicological risk assessments, and testing strategies for medical devices and combination products.
  • Collaborate closely with R&D, Quality, Regulatory, and Manufacturing to ensure material and process changes are biologically safe.
  • Guide biological evaluation programs for complex devices and combination products.
  • Partner with materials science, chemistry, and analytical testing teams to establish integrated strategies for material characterization and safety.
  • Serve as a key advisor to product development teams to enable safe, compliant, and efficient product launches.
  • Engage with external experts and standards organizations to influence future regulatory and technical frameworks.
Requirements
  • Bachelor's degree required
  • Ph.D. or M.S. required in Biology, Biomedical Engineering, Materials Science, Toxicology, or related discipline, preferably with a specialism relating to medical devices
  • Minimum of 12 years of relevant experience required in biocompatibility, toxicology, materials safety, or related within the medical device or combination product
  • Minimum of 5 years of leadership experience, including managing scientific teams and cross-site functions
  • Proven record of leading global biocompatibility or toxicology programs supporting regulatory submissions and product approvals
  • Expert in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993
  • Strong understanding of extractables and leachables, chemical characterization, and toxicological risk assessment methodologies
  • Excellent scientific judgment and strategic thinking
  • Exceptional communication, collaboration, and influencing skills
  • Demonstrated ability to lead in a global organization
  • Regulatory interaction experience (FDA, notified bodies, etc.) strongly preferred
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