Our client a medical device company in Limerick is looking to hire a Toxicology Project Coordinator for their site on a permanent basis.
As a Project Coordinator you will primarily working with products in the Medical Segment, your major responsibility will be to support programs to address biocompatibility and nonclinical safety of medical devices intended for registration. You'll be tasked with helping in the development of evaluation programs and preparing and reviewing required documentation. You'll be supporting gap assessment related to European Union Medical Device Regulation.
Key features of the role include:
- Contribute to the design, execution and interpretation of preclinical safety, biocompatibility, analytical chemistry, and toxicological evaluation programs according to relevant regulatory requirements; including review of literature and assessment of compliance.
- Collaborate with Corporate Preclinical Development & Toxicology (CPDT) SMEs, project teams, business unit regulatory affairs staff, R&D staff and outside suppliers as required to help define product testing requirements and coordinate with the project team to provide CPDT deliverables.
- Provide information relevant to testing to CPDT Project Management including device characteristics, clinical use and project/team milestones, as appropriate.
- Support and provide biocompatibility- related process training as needed.
- Maintain historical databases and perform searches of historical data, as needed.
- Maintain knowledge of medical device regulations to assure compliance and conformance of CPDT programs
- BA/MA degree in toxicology or a related field
- 2-6 years of pre-clinical medical device development experience.
- With a good level of educational achievement, you have a broad background in biology, toxicology and analytical chemistry including familiarity with recent methodologies and evaluation techniques (ISO 10993).
- Experience from a US or EU medical device setting
- Ability to communicate and work effectively with national and international, internal and external teams
- Ability to multitask and operate effectively within a diverse work environment
- Team oriented mindset, strong interpersonal skills and customer focus
- Excellent scientific written and verbal communication skills
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