Our client a medical device company in Limerick is looking to hire a Senior Toxicology Scientist for their site.
As a Senior Nonclinical Scientist based in the Research Centre primarily working with products in the Medical Segment, your major responsibility will be to manage programs as the business level SME to address biocompatibility and nonclinical safety of medical devices intended for registration.
You'll be tasked with helping in the development of toxicological evaluation strategies and programs and preparing and reviewing required documentation. You'll be supporting gap assessment related to European union Medical Device Regulation.
Other key features of the role include:
- As an SME, leading the design, execution and interpretation of preclinical safety, biocompatibility, analytical chemistry, and toxicological evaluation strategies and programs according to relevant regulatory requirements; including review of literature and assessment of compliance
- Collaborating with the 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
- Participating on Project Core Teams as an SME, providing Biocompatibility and other CPDT related input as necessary
- Leading the authoring and/or review of documents as required for regulatory registration/submission, regulatory compliance and support of product marketing
- Maintaining historical databases and performs searches of historical data, as needed
- Maintaining knowledge as an SME of medical device regulations to assure compliance and conformance of CPDT programs for evaluation of medical device and other products
- Engaging in Standards review relevant to biocompatibility through participation in various global committees that develop standards as appropriate
- BA/MA/PhD degree in toxicology
- 4-8 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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