Biocompatibility Lead for Medical Devices (NPD/LCM)

ConvaTec Inc; Shotton; Vor Ort; GBP 90.000 - 120.000; Vollzeit

Zusammenfassung

Convatec is seeking a Senior Biocompatibility Specialist within the Applied Research organization in the Biomedical Sciences team. The role focuses on executing biocompatibility projects for NPD, LCM and research, applying ISO 10993 standards and QMS requirements.

The candidate will design biological evaluations, analyze results, and prepare documentation, while collaborating with cross-functional teams to derisk programs and deliver regulatory-compliant reports globally.

Qualifikationen

• BS in Biomedical Engineering/Biology; MS/PhD preferred
• 5+ years in biocompatibility evaluations or toxicological risk assessments
• Strong knowledge of ISO 10993 standards and biocompatibility methods
• Experience designing biological evaluation plans and regulatory summaries
• Excellent communication and cross-functional collaboration skills

Aufgaben

• Deliver biocompatibility evaluations for new and existing devices with cross-functional teams
• Oversee external laboratories to conduct biocompatibility studies
• Develop and revise biological evaluation protocols and regulatory summaries
• Analyze data and report results to project teams
• Prepare documentation in line with ISO 10993 and QMS
• Communicate project updates to stakeholders

Kenntnisse

Biocompatibility expertise

Cross-functional collaboration

Data analysis

Regulatory understanding

Project management

Ausbildung

Bachelor's degree in Biomedical Engineering/Biology/Toxicology

MS or PhD preferred

Jobbeschreibung

Convatec is seeking a Senior Biocompatibility Specialist within the Applied Research organization in the Biomedical Sciences team. The role focuses on executing biocompatibility projects for NPD, LCM and research, applying ISO 10993 standards and QMS requirements.

The candidate will design biological evaluations, analyze results, and prepare documentation, while collaborating with cross-functional teams to derisk programs and deliver regulatory-compliant reports globally.