Biocompatibility Expert

About Terumo BCT

Terumo BCT is a leading global medical device company that specializes in the development and manufacturing of medical devices and related products. Our company is committed to advancing healthcare solutions worldwide and making a positive impact on patients' lives.

Job Summary

We are seeking a highly skilled and experienced Biocompatibility Specialist to join our team. As a Biocompatibility Specialist, you will play a critical role in ensuring the safety and efficacy of our products by developing and implementing biocompatibility testing and evaluations for biological hazards.

Key Responsibilities

• Partner closely with manufacturing, engineering, and other functional groups to ensure regulatory compliance and develop solutions to problems of moderate to intermediate complexity.
• Support global regulatory submissions of medical devices and pharmaceutical products.
• Provide chemistry support to global sites, including selecting appropriate chemical analysis during investigations, interpreting data, and EtO residual validations and analysis.
• Ensure adherence to relevant quality system regulations and standards, such as FDA regulations (e.g., 21 CFR Part 820), ISO 13485, and Terumo BCT Standard Operating Procedures.
• Stay abreast of relevant regulations, standards, and guidelines related to biocompatibility testing and ensure compliance with regulatory requirements, such as FDA, EU MDR, and other applicable regulations.
• Help oversee biocompatibility testing activities, including selecting appropriate tests, coordinating with external testing laboratories, and ensuring that testing protocols are followed accurately.
• Interpret chemistry data while conducting risk assessments to identify potential biological hazards associated with medical devices, pharmaceuticals, and combination products, and develop risk mitigation strategies to ensure product safety.
• Maintain accurate and comprehensive documentation related to biocompatibility testing, including test plans, protocols, reports, and regulatory submissions.
• Collaborate with internal departments, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to integrate biocompatibility requirements into product development processes and ensure alignment with Quality objectives.
• Provide support for the development, implementation, and maintenance of Quality Management Systems related to biocompatibility testing, including participating in internal audits and corrective/preventive action activities.
• Help identify opportunities for process improvements and efficiencies in biocompatibility testing procedures, documentation practices, and Quality Management Systems.
• Provide training and education to internal stakeholders on biocompatibility testing requirements, principles, and best practices.
• Interpret, execute, and recommend modifications to operating policies where appropriate, and modify, update, and execute established programs to achieve and maintain a state of compliance.
• Provide support to the internal and external audit program as applicable.
• Lead and participate in continuous improvement.

Requirements

• Bachelor's degree in a relevant scientific field (e.g., Chemistry, Biology, Bioengineering) required. Chemistry degree is preferred.
• Minimum 5 years of experience in chemistry and biocompatibility testing and evaluation, preferably in the medical device or pharmaceutical industry.
• Strong understanding of regulatory requirements and standards related to biocompatibility testing (e.g., ISO 10993, FDA guidance documents).
• Excellent analytical, problem-solving, and decision-making skills.
• Ability to effectively communicate complex technical information both verbally and in writing to diverse audiences.
• Familiarity with Quality Management Systems (e.g., ISO 13485) and regulatory submissions is preferred.
• Able to orchestrate multiple activities at once under limited direction.
• Proven project leadership and project management skills.
• Proficiency in technical writing.
• Knowledge and use of relevant PC software applications and skills to use them effectively.

Travel and Location

This role may require occasional travel to external testing facilities or Terumo BCT sites based on business needs.

Lakewood, Colorado is strongly preferred, however, we are open to remote candidates.

Physical Requirements

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.