Senior Biocompatibility Scientist

Aerogen

Galway, Ireland

What is the role?

This role supports the successful introduction and ongoing compliance of products by defining and executing an appropriate biological safety strategy across the product life cycle. This includes planning and overseeing biocompatibility evaluations (e.g., ISO 10993), generating evidence for regulatory submissions, and maintaining the organisation’s commercial footprint through sustained market access and post-market change support.

The successful candidate will work with internal Technology, Product and Process Development groups and external partners to lead, plan, organise biological safety risk assessments on medical devices in accordance with current national and international regulations. This is inclusive of the development of the testing strategies to minimise risk to meet the applicable regulatory requirements.

What are the key responsibilities? 

Subject Matter Expert: Serve as the primary expert for all biocompatibility and microbiology activities at Aerogen, providing authoritative guidance across product development, manufacturing and supplier processes;
Technical Excellence: Advise on the selection of materials and the development of robust, scientifically justified testing strategies, ensuring optimal outcomes for device safety and efficacy, considering product development, product change assessments, including supplier change notifications and process changes;
Regulatory Knowledge: Interpret and apply relevant quality system and regulatory requirements, including ISO, FDA, MDR, and AAMI standards and regulations, to all biocompatibility and microbiology processes. Conduct relevant gap analyses as required and implement appropriate changes or additional test strategies based on these assessments;
Compliance and Documentation: Ensure full compliance with internal and external quality requirements, maintaining accurate and up-to-date documentation for all biocompatibility and microbiology activities;
Collaboration: Liaise and coordinate with external laboratories and contract testing services, ensuring testing is performed to the highest standards and in accordance with regulatory expectations and state-of-the-art industry standards;
Vendor Management: Establish contacts and monitor service performance of the selected vendors;
Test Lab Due Diligence: Perform due diligence in the selection of appropriate accredited test labs for test strategy development and test execution;
Project Support: Support and lead cross-functional project teams in the planning, execution, and validation of biocompatibility and microbiology testing, contributing to project deliverables and timelines;
Testing Requirements Leadership: Support and lead Project Teams with respect to defining biocompatibility and microbiological testing & validation requirements as deemed required;
Risk Assessment: Conduct risk-based change assessments, clearly communicating testing strategies and outcomes to stakeholders and providing recommendations for risk mitigation;
Audit Support: Assist in the preparation for and support of external audits by Notified Bodies and regulatory authorities such as the FDA, ensuring readiness and effective response to queries related to biocompatibility and microbiology;
Internal Education: Educate internal colleagues across departments and divisions in biological safety evaluations, risk assessments, and chemical characterisation;
Professional Development: Maintain and expand scientific and medical knowledge in biocompatibility and microbiology through ongoing professional development, training, and engagement with relevant scientific communities;
Regulator Interactions: Prepare response and engage with global regulators as applicable on interactions on issues concerning biocompatibility and microbiological matters

What education and experience are required?

Minimum of relevant Level 8 Degree in Science/Technology/Engineering;
Masters in Science/Technology/Engineering preferred (emphasis on materials);
Minimum of 7 years’ experience in a quality engineering/materials/microbiology role, preferably in the Medical Devices-Industry. Biocompatibility experience is desired for long-term devices;
Experience in interpretation of Analytical techniques including but not limited to, GC, HPLC, IR, Atomic Absorption, & GC-MS;
Working experience in FDA, MDR, USP, AAMI, ANSI, ASTM, and ISO requirements applicable to biocompatibility, microbiology and quality management system.

What key skills will make you great at the role? 

Strong knowledge of biocompatibility regulations and standards (FDA, USP, MDR, AAMI, ANSI, ASTM, ISO), including ISO 10993 and ISO 18562 series;
Background in microbiology, analytical chemistry, and materials science;
Experience in supplier and internal auditing;
Highly organised with strong attention to detail; proven ability to meet deadlines and deliver results;
Effective communicator, able to tailor messaging to different audiences;
Collaborative team player with the ability to work independently to achieve goals;
Solid understanding of ISO 13485, MDR, and FDA QMS regulations;
Strong problem-solving skills with a proactive approach to solutions;
Proficient in MS Office and statistical analysis tools (e.g. Minitab), including chemical calculations;
Experience applying risk assessment methodologies in product development.