- Abbott (St. Paul, MN)
- …Our 114,000 colleagues serve people in more than 160 countries. ** Director , Biocompatibility ** **Position Summary** Responsible for Biocompatibility ... ISO 10993 series. **Principal Responsibilities** + Manage direct staff conducting biocompatibility evaluation of medical devices across multiple divisions of Abbott… more
- Edwards Lifesciences (Irvine, CA)
- …BD at bd.com **How you will make an impact:** * Serve as a GLP study director managing in vitro and in vivo biocompatibility safety studies intended to support ... and closure of in-house in vitro and in vivo biocompatibility GLP studies including Cytotoxicity (Medium Eluate Method), Hemolysis,...for (Preferred):** * Professional experience as a Sr Study Director or SME Scientist in the medical device or… more
- GE HealthCare (FL)
- …supporting, and life sustaining devices, understanding requirements for biocompatibility , reprocessing, medical software, cybersecurity, and market requirements. + ... Leads a team of regulatory professionals in execution of regulatory affairs tasks in support of the businesses. + Prepares global regulatory submissions by working across the regulatory organization and cross functionally with other functions such as… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …cycle management with a focus on Material Sciences (including biocompatibility , extractables and leachables, material attributes, etc.), ensuring that regulatory ... filings are of high quality and right first time + Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations, with emphasis on Material Sciences, and establishes mechanisms to communicate them to relevant stakeholders,… more
- embecta (Andover, MA)
- …medical devices developed by embecta. Reporting up to the Associate Director , R&D - Verification and Validation, the successful candidate brings prior ... compliance standards; including but not limited to ISO 10993 standard for biocompatibility , transportation and distribution testing per ASTM D4332 and ASTM D4169… more
- BD (Becton, Dickinson and Company) (Sandy, UT)
- …manufacturability, quality, safety and time to market. This role reports into Director of PIVC Design Engineering and works closely with a multi-functional team ... analysis and risk management techniques + Familiarity with ISO10993 and ISO13485 biocompatibility testing standards + Ability to read and understand drawings and… more