Biocompatibility Engineer - ISO 10993 & Regulatory Expert

ATR International; Minneapolis (MN); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

ATR International is seeking a Biocompatibility Specialist to evaluate safety and compatibility of medical devices with biological systems. You will plan and place biocompatibility testing per ISO 10993 standards, collaborate with cross-functional teams, analyze data, and support regulatory submissions.

You will stay current with evolving global standards and contribute to strategies for new products and post-market activities from a biocompatibility perspective.

Competenze

• Experience in a regulated industry.
• Knowledge of international and domestic regulations associated with biocompatibility.
• Experience with assessing biocompatibility risk per ISO 10993 standards.

Mansioni

• Design and execute biocompatibility assessment plans and reports in accordance with ISO 10993 and regulatory requirements.
• Interface with laboratories to coordinate testing activities, ensure compliance, and resolve technical issues.
• Review and interpret laboratory test results; document findings in technical reports and regulatory submissions.
• Support product development lifecycle activities, including design changes and post-market surveillance, from a biocompatibility perspective.
• Stay current with evolving global biocompatibility standards, guidance documents, and regulatory expectations to ensure ongoing compliance.

Conoscenze

Regulatory experience

Biocompatibility knowledge

ISO 10993 risk assessment

Formazione

University degree

Advanced degree

Descrizione del lavoro

ATR International is seeking a Biocompatibility Specialist to evaluate safety and compatibility of medical devices with biological systems. You will plan and place biocompatibility testing per ISO 10993 standards, collaborate with cross-functional teams, analyze data, and support regulatory submissions.

You will stay current with evolving global standards and contribute to strategies for new products and post-market activities from a biocompatibility perspective.