Senior Biosafety & Sustainability Engineer — Med Devices

Ambu; Penang; Presencial; MYR 120 000 - 180 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Personal development opportunities

Employee benefits program

Resumo da oferta

Ambu A/S seeks a Senior Biosafety & Sustainability Engineer I to be based in our Global Hub, Penang. This role reports to the Section Manager, Biosafety & Sustainability, and focuses on safety, material compliance, and sustainability across the product lifecycle.

Responsibilities include preparing biological and toxicological assessments, supporting regulatory submissions, and monitoring safety standards (ISO 10993, ISO 18562, REACH, RoHS).

Qualificações

• Bachelor's or Master's in a related scientific discipline.
• 2) Knowledge of ISO 10993, ISO 18562, ISO 14971, ISO 13485, FDA guidance, REACH, RoHS.
• 3) Experience with material technologies in medical devices.
• 4) Ability to interpret technical and regulatory information from multiple sources.
• 5) Experience in medical device or pharmaceutical fields.

Responsabilidades

• Prepare biological evaluation and toxicological risk reports, FDA submissions, and material compatibility assessments.
• Support biosafety and material compliance evaluation throughout the product lifecycle.
• Plan, execute, and interpret biological and chemical assessments.
• Identify biosafety-related activities, risks, dependencies, testing needs, and timelines for development projects.
• Collaborate with cross-functional teams and external partners for regulatory submissions, audits, and inquiries.
• Monitor ISO 10993, ISO 18562, and related standards and regulations affecting medical device safety and chemical compliance.
• Coordinate collection and management of sustainability data and documentation.
• Evaluate changes for impacts on sustainability documentation and implement necessary updates.

Conhecimentos

Analytical skills

Problem-solving

English communication

Sustainability interest

Cross-functional collaboration

Global environment adaptability

Regulatory interpretation

Regulatory information gathering

Formação académica

Bachelor's or Master's in Polymer Science

Related scientific discipline

Ferramentas

Excel

AI skills

Descrição da oferta de emprego

Ambu A/S seeks a Senior Biosafety & Sustainability Engineer I to be based in our Global Hub, Penang. This role reports to the Section Manager, Biosafety & Sustainability, and focuses on safety, material compliance, and sustainability across the product lifecycle.

Responsibilities include preparing biological and toxicological assessments, supporting regulatory submissions, and monitoring safety standards (ISO 10993, ISO 18562, REACH, RoHS).