Senior Biocompatibility Engineer – ISO 10993 & Regulatory

Planet Pharma; Saint Paul (MN); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Planet Pharma Group in Minnesota seeks an experienced biocompatibility specialist to evaluate safety and ISO 10993 compliance for medical devices. The role involves planning and placing biocompatibility testing, coordinating with laboratories, and preparing technical reports for regulatory submissions.

You will analyze data, support product development, and address biocompatibility issues during development and post-market activities, ensuring ongoing regulatory compliance.

Qualifikationen

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

Aufgaben

• 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 any 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.

Kenntnisse

Regulated industry experience

ISO 10993 knowledge

Biocompatibility risk assessment

Ausbildung

University degree (relevant field)

Jobbeschreibung

Planet Pharma Group in Minnesota seeks an experienced biocompatibility specialist to evaluate safety and ISO 10993 compliance for medical devices. The role involves planning and placing biocompatibility testing, coordinating with laboratories, and preparing technical reports for regulatory submissions.

You will analyze data, support product development, and address biocompatibility issues during development and post-market activities, ensuring ongoing regulatory compliance.