Senior Medical Device Toxicologist – Biocompatibility & Risk

Boston Scientific; Galway; On-site; EUR 70,000 - 100,000; Full time

Job summary

Boston Scientific in Galway, Ireland, seeks a Medical Device Toxicologist III to provide technical support for biocompatibility and toxicology processes, contributing to biological evaluation for new product development, sustaining activities, and regulatory submissions.

You will author biocompatibility tests and risk assessments, mentor junior staff, and ensure patient safety and product quality within Global Preclinical and Quality Management System requirements.

Qualifications

• Honours Degree (Level 8) in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering).
• 3-5 years of related medical device / related industry experience.
• Knowledge of the biological evaluation of medical devices and / or drug-device combination products.
• Masters degree (Level 9) in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering). Will consider candidates with an Masters (Level 9) and 2+ years of related experience.
• A PhD degree in Toxicology or related field (biology, chemistry, biochemistry, biomedical engineering). Will consider candidates with an PhD and 1+ years of related experience.
• Applied knowledge and understanding of toxicology principles and best practices.
• Working knowledge of risk assessment methodologies, including the toxicological evaluation of medical device materials.
• Working knowledge of regulatory standards and global regulatory requirements with respect to medical device and combination products.
• Experience supporting GLP and nGLP studies

Responsibilities

• Providing technical support for biocompatibility and toxicology processes to meet global business objectives.
• Contributing to biological evaluation of medical devices for new product development, sustaining activities, and regulatory submissions.
• Authoring biocompatibility and chemical characterization test plans, assessments and reports.
• Authoring or assisting to author toxicological risk assessments.
• Providing informal guidance to junior team members on biocompatibility and toxicology processes.
• Maintenance of communication with internal customers on biocompatibility and toxicology issues.
• Consulting on testing strategies for investigational and strategic device development programs.
• Applying regulatory requirements and internal procedures to support medical device submissions.

Skills

Biocompatibility knowledge

Toxicology expertise

Regulatory knowledge

GLP/nGLP experience

Communication skills

Education

Honours Degree (Level 8) in Toxicology or closely related field

Masters degree (Level 9) in Toxicology or closely related field

PhD in Toxicology or related field

Job description

Boston Scientific in Galway, Ireland, seeks a Medical Device Toxicologist III to provide technical support for biocompatibility and toxicology processes, contributing to biological evaluation for new product development, sustaining activities, and regulatory submissions.

You will author biocompatibility tests and risk assessments, mentor junior staff, and ensure patient safety and product quality within Global Preclinical and Quality Management System requirements.