This position within Nonclinical Safety will support the B+L Surgical and Vision Care Business Units by ensuring that adequate biocompatibility documentation exists for all new and existing medical device products to meet current and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993 series.
Supports MDR work project (technical files): documentation specialist, in compliance to current standards; needs some experience in non-clinical studies or education – understand the science and update the documents
- Must be in Rochester, NY to support MDR
Scope of Position: Individual contributor to product life cycle management activities and to a lesser extent to new product development activities.
R&D organization (Regulatory Affairs, Quality, Analytical Chemistry, Formulations, Engineering, Project Management) and external vendors (CROs and consultants)
Degree in Toxicology, Regulatory Affairs, or related discipline. MS with experience in toxicology or related discipline with a minimum of 2 years relevant industry experience; BA/BS with a minimum of 5 years relevant industry experience.·
Special Skills: Computer Literacy with skills in Microsoft Excel, Word, Project and PowerPoint. Strong Communication, Organization, Report Writing, and Presentation skills a must. Must be able to develop working relationships with various internal core competencies, manage outside suppliers, influence others outside of their immediate control and lead team members
Entry Level - 5 years in Toxicology and/or Regulatory Affairs in pharmaceutical and/or medical device industry