Senior Biosafety & Sustainability Engineer I

Ambu; Penang; On-site; MYR 120,000 - 180,000; Full time

Benefits offered by this job

Personal development opportunities

Employee benefits program

Job summary

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).

Qualifications

• 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.

Responsibilities

• 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.

Skills

Analytical skills

Problem-solving

English communication

Sustainability interest

Cross-functional collaboration

Global environment adaptability

Regulatory interpretation

Regulatory information gathering

Education

Bachelor's or Master's in Polymer Science

Related scientific discipline

Tools

Excel

AI skills

Job description

Ambu A/S is currently looking for a Senior Biosafety & Sustainability Engineer I to be based in our Global Hub, Penang. You will be reporting to the Section Manager, Biosafety & Sustainability.

Key Responsibilities

Your main responsibilities will include:

• Prepare biological evaluation report, toxicological risk assessment, biological equivalence report, FDA 510k submission and material compatibility assessment.
• Support the biological safety and material compliance evaluation of medical devices throughout the product lifecycle, including risk assessment.
• Plan, execute, and interpret biological and chemical assessments.
• Contribute to project planning by identifying biosafety-related activities, risks, dependencies, testing needs, and timelines for product development and change projects.
• Collaborate with cross-functional teams and external partners to support project execution, regulatory submissions, audits, and customer inquiries.
• Monitor and interpret relevant regulations, standards (ISO 10993, ISO 18562), and industry developments related to medical device safety, materials, and chemical compliance (REACH, RoHS, CLP).
• Support the collection, review, and management of product sustainability data and documentation to ensure accuracy and completeness throughout the product lifecycle.
• Evaluate product, material, and manufacturing changes for potential impacts on sustainability-related documentation and requirements, and support implementation of necessary updates.

Suggested candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

• Bachelor's or Master's degree in Polymer Science, Polymer Engineering, Materials Science, Materials Chemistry, Chemical Engineering, Toxicology, Biomedical Engineering, or a related scientific discipline.
• Knowledge of medical device regulations and standards such as ISO 10993, ISO 18562, ISO 14971, ISO 13485, FDA guidance, REACH, and RoHS.
• Understanding of polymer and material technologies commonly used in medical devices.
• Familiarity with material characterization, chemical composition, toxicological risk assessment, chemical characterization, or analytical testing.
• Ability to evaluate and interpret technical, scientific, and regulatory information from multiple sources.
• Relevant experience from medical device or pharmaceutical company.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills in English.
• Interested in sustainability
• Good with excel skills and AI skills
• Able to work effectively in a global, cross-functional environment.

Ambu – a visionary and international workplace where your efforts matter. Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

• We offer great opportunities for personal development.
• We offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.