Senior Biocompatibility Scientist – Orthopedic Devices

Mainz Brady Group; Denver (CO); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

Mainz Brady Group is seeking a Senior Research Scientist to lead biological safety and biocompatibility investigations for orthopedic medical devices. The role emphasizes ISO 10993 compliance, preclinical in vivo research, and cross-functional collaboration with engineering, regulatory, and quality teams.

The ideal candidate brings hands-on preclinical experience, strong regulatory knowledge, and excellent scientific communication to drive safety evaluations and regulatory readiness across

Qualifications

• Master's degree with 5+ years of relevant experience or PhD/DVM with 3+ years preferred.
• Experience with ISO10993 biological evaluation and biocompatibility.
• Demonstrated ability to develop, review, and interpret biological safety risk assessments and technical documentation.
• Proven project management experience in regulated medical device settings.
• Excellent scientific writing, analytical, problem-solving, and presentation skills.

Responsabilités

• Lead and support investigations, research initiatives, and remediation activities for orthopedic devices.
• Develop, review, and approve protocols, reports, and biological safety risk assessments per ISO 10993.
• Design and support preclinical studies including in vivo testing and large animal models.
• Develop biological evaluation plans and testing strategies for safety and regulatory compliance.
• Coordinate biological safety testing with internal teams and external labs.
• Provide scientific and technical guidance for investigations, risk assessments, and remediation initiatives.
• Prepare biological safety documentation for regulatory submissions.
• Analyze and present preclinical and biological data to stakeholders.
• Collaborate with design, process engineering, manufacturing, quality, regulatory, and research teams.
• Serve as SME in biological safety and orthopedic device research.
• Manage research activities, timelines, and lab studies.
• Engage with external researchers and key opinion leaders.
• Present findings to leadership, regulatory stakeholders, and scientific audiences.

Connaissances

Biological safety

Biocompatibility

ISO 10993

Regulatory knowledge

Preclinical in vivo research

Project management

Scientific writing

Cross-functional collaboration

Medical device R&D

Data interpretation

Formation

Master's degree in Biomedical Science/ Biology/ Toxicology/ Materials Science/ Biomedical Engineering

PhD or DVM preferred

Bachelor's with significant directly relevant experience

Description du poste

Mainz Brady Group is seeking a Senior Research Scientist to lead biological safety and biocompatibility investigations for orthopedic medical devices. The role emphasizes ISO 10993 compliance, preclinical in vivo research, and cross-functional collaboration with engineering, regulatory, and quality teams.

The ideal candidate brings hands-on preclinical experience, strong regulatory knowledge, and excellent scientific communication to drive safety evaluations and regulatory readiness across