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Clinical Sciences Specialist

Job Title: Clinical Sciences Specialist
Contract Type: Permanent
Location: Cork
REF: 92799
Job Published: about 1 month ago

Job Description

Contact: Bimi Felix
Telephone: 086 8395533

Clinical Sciences Specialist
Our client, a medical device company in Cork are currently looking to recruit a Clinical Sciences Specialist for their site.

Basic Function
  • Provide technical support to various areas of the business related to biocompatibility, cleaning, disinfection and sterilization of reusable and single use medical devices.
  • Develop compliant testing protocols and guidelines for new product development and product changes of both terminally sterilized and reusable products
  • Coordinate and complete projects and project deliverables with general supervision in collaboration with cross functional groups such as R&D, Operations, and Marketing
  • Interpret, assess, analyze and apply international standards related to sterilization, cleaning, disinfection and biocompatibility
  • Work on technical problems of limited scope; understands implications of work and makes recommendations for solutions
  • Participate in the development or revision of quality system procedures and quality improvement initiatives associated with clinical sciences
  • Support resolution to product quality issues such as customer complaints, adverse events, product field actions, and non-conformances
  • Involvement with industry groups such as AAMI, ISO, etc.
  • Perform gap assessments to new or changing standards
  • Knowledge of products and processes within his/her business unit
  • Other duties and projects as assigned
  • Estimated travel of 10% to support industry meetings, suppliers, etc.
Physical Requirements
  • Light work: Exerting up to 20 pounds of force occasionally and/ or up to 10 pounds of force frequently and/or a negligible amount of force constantly to move objects.
  • Must be able to review printed materials.
  • Must be able to communicate telephonically
  • Must be able to use common office equipment (e.g. calculator, PC, telephone, etc.)
Mental Requirements
  • Ability to interface effectively with health care professionals and medical device customers
  • Must be able to interpret medical terminology
  • Must be able to work independently but also capable of collaboration and participation in teams
  • Must be highly customer service oriented
Qualifications/Work Experience Preferred
  • Knowledge of FDA, GMP, ISO, and other medical device regulatory requirements and standards
  • Knowledge of cleaning, disinfection and sterilization techniques, microbiology concepts, standards, practices and procedures
  • Knowledge of biocompatibility testing concepts, standards, practices and procedures
  • Adequate interpersonal skills with the ability to effectively communicate and lead through influence
  • Strong time management skills, ability to plan and manage multiple priorities
  • Ability to accept and manage project risk to drive concurrent projects forward
  • Working knowledge of test method development
  • Working knowledge of business applications such as Microsoft Office (Word, Excel, PowerPoint, etc.)
  • 0-2 years of experience in medical device product development and or testing

Education/Special Training Required
  • B.S. in a related curriculum such as Biology, Microbiology, Chemistry, or Biomedical Engineering

For further information on this Clinical Sciences Specialist role in Cork please contact Bimi Felix on 086 8395533 /
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