Job Description
Our client, a blue-chip Medtech company based in Galway, currently seeks a Biocompatibility Toxicology Scientist who will perform or coordinates a wide variety of chemical and biological tests working in compliance with company SOPs, regulatory requirements, etc. This is a fixed term contract, on-site role.
The successful candidate will conduct biocompatibility, chemistry and toxicology testing related to new product investigation and provide input on strategic device development programs during technology and product development. Such work will include review and completion of Biocompatibility Assessments and Reports as necessary, including authoring such reports.
This hire will work to biocompatibility processes, ensuring biocompatibility and toxicology related information and data are accurate, reliable, and in line with global preclinical objectives and QMS.
This role requires a person with good communication skills, ability to manage various stakeholders in a team environment. Leadership experience is preferred.
Responsibilities for Biocompatibility Toxicology Scientist:
Assess biocompatibility and toxicology testing/data/information for medical devices and pharmaceutical materials, which may include issues related to materials of animal origin, colorant additives, exposure assessments of chemicals, and other chemical toxicities as delegated.
Ensure patient safety and product quality through testing processes, aligned with SOPs and in compliance with regulatory requirements.
Validates new and existing products to ensure compliance with current biocompatibility regulatory standards.
Provide technical scientific guidance in the development of product design, specifications and associated test methods.
Participates in product development teams to ensure validation of products to agreed timelines.
Assists in documentation of validations for regulatory submissions.
Other duties as assigned, such as: approval of test reports.
Understands and complies with all the regulations governing the quality systems.
Requirements for Biocompatibility Toxicology Scientist:
Honours Bachelor’s Degree in Bioscience, Toxicology or Chemistry or equivalent discipline.
3+ years’ experience of biological, biocompatibility and toxicology testing, working in Pharmaceutical or Medical Devices industry to FDA requirements.
Knowledge of 10993 and advantage.
Application of company policies and procedures, when analysing and interpreting data to make evidence base decisions and solutions to solve problems.
Good interpersonal and communication (written and verbal) skills are required.
Stakeholder management & influencing skills.
Proven decision-making ability.
Please contact Larry on 01- 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
Follow us on: Facebook, Linked-in, twitter