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Project Coordinator (LOA007179 )

Location: Limerick
Experience:3-4 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: Documentation Specialist, Project Lead

Project Coordinator
As a Project Coordinator with this company, 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.

Other 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 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

Experience required:

  • BA/MA degree in toxicology or a related field and have 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

If you would like further Information you can contact the recruiter directly:

Libby Ryan | Tel: +353 (0) 1 507 9254


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