Biocompatibility Subject Matter Expert

As Biocompatibility Subject Matter Expert, you will be the Site Subject Matter Expert for all biocompatibility and microbiology activities. You will work closely with internal and external stakeholders to ensure products meet the highest standards of safety, compliance and performance in accordance with national and international medical device regulations: ISO 10993 & ISO 18562

What You’ll Do:

• Lead Biocompatibility & Microbiology Strategy: Define testing strategies, ensure regulatory compliance, and drive innovation in materials selection.
• Ensure Compliance & Risk Management: Stay ahead of evolving regulatory standards (ISO, FDA, MDR, AAMI) and guide the business on critical updates.
• Collaborate with Cross-Functional Teams: Support R&D, product development, and process teams with expert advice on biological safety and risk assessments.
• Engage with External Partners: Manage relationships with accredited test labs and ensure high-quality service for biocompatibility and microbiology testing.
• Support Audits & Regulatory Reviews: Play a key role in external audits, including Notified Body and FDA inspections.
• Educate & Advocate: Train internal teams on biocompatibility evaluations, risk assessments and chemical characterization.

What You’ll Need:

• Level 8 Degree in Science, Technology, or Engineering.
• Minimum 7 years’ experience in a biocompatibility, quality engineering, materials, or microbiology role (preferably in Medical Devices).
• Expertise in ISO 10993, ISO 18562, and biocompatibility/microbiology regulations.
• Hands-on experience with analytical techniques (GC, HPLC, IR, Atomic Absorption, GC-MS).
• Knowledge of FDA, MDR, USP, AAMI, ANSI, ASTM, ISO 13485 and QSMR requirements.
• Strong problem-solving, organizational and communication skills.
• Experience with supplier/internal auditing and statistical tools like Minitab.