A client of mine a leading medical device company in Galway is looking to hire a Medical Device Toxicologist on a permanent basis.
Provides support for the biocompatibility and toxicology processes and related technical support to assigned business divisions in support of new product development, regulatory submissions and manufacturing and engineering changes to meet business objectives. Responsible for the conduct of biological evaluations, chemical characterization, and toxicological risk assessments as assigned.
* Provide support for biocompatibility processes initiated by department management and ensure biocompatibility and toxicology related information and data are accurate, reliable, and support business objectives as consistent with Global Preclinical objectives and Quality Management System requirements.
* Demonstrate a primary commitment to patient safety and product quality.
* Under direction and mentorship of more senior staff,
* Develop Biocompatibility and chemical characterization test plans, author Biocompatibility Assessments and Reports, and assess test data and reports as necessary to support business objectives.
* Author toxicological risk assessments as assigned to support divisional objectives.
* Provides input on the regulatory requirements related to medical device submissions. on procedures, techniques, concepts and approaches used at divisional levels for biocompatibility and toxicology programs
* Serves as a resource for biocompatibility and toxicology information for medical devices and pharmaceutical materials.
* Maintains communications with internal customers on biocompatibility and toxicology issues and supports problem solving and resolution related to biocompatibility assessments, chemical characterization, and toxicological risk assessments
* Provides input on biocompatibility, chemistry, and toxicology testing related to new investigational and strategic device development programs during Technology and Product development programs (TDP/PDP).
* Participates as assigned in a Biocompatibility Training Program for all functional groups of device development teams based on standards and regulatory requirements.
* Provides input on procedures, techniques, concepts and approaches used at divisional levels for biocompatibility and toxicology programs.
Education and Requiremnets:
* Honours Degree (NFQ level 8/ 240 Credits) in Science or a similar discipline e.g. Biomedical, Toxicology, Chemistry, Microbiology
* Min. 3-5 years relevant experience in a science-based role in a highly regulated environment
* Medical Device experience would be a high advantage
* Strong Technical writing/ documentation skills
* Project Management experience
*please note that this role isn’t a lab based role
*as a part of this role you will be initially working remotely with a view to work 50% on site in the next few months
For further information on this Toxicologist role in Galway please contact Clara Burke (phone number removed) / email@example.com
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Job Type: Permanent
Location: Galway, County Galway
To apply for this job please visit www.cv-library.ie.