Clinical Sciences Specialist

Hero Recruitment

Cork

Contact: Bimi Felix. Email: bimi@hero.ie. 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. Responsibilities. 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 / bimi@hero.ie. Check out all our open jobs on our HERO Recruitment website – www.hero.ie. Please Note: HERO Recruitment will not forward your details to any company without your prior approval. This job originally appeared on RecruitIreland.com.

2252 days ago