Sr. Biocompatibility Scientist

Job Description Summary

We areseekingan experienced high caliber Scientist II who will make an important contribution to patient safety by supporting projectsandprogramsrelated tothebiocompatibility of medical devices materials and processes. This role willbe responsible forsubmittingtest devicestolaboratoriesmanagingtest progress and serving as the primary contact for the labs.The Scientist IIwillworkcloselywithcross-functionalteamstoprovidebiocompatibilitydeliverables(biocompatibility plans/reports/justifications)incompliancewithglobalregulatoryrequirementssuchasISO10993.Therolerequirescomprehensiveknowledgeof the medical device biocompatibility discipline throughout the product lifecycle and knowledge of biocompatibility regulations and guidanceaffectingassigned devices (Class I to Class III).The candidate mustbe able tosupportthebiocompatibilityteamincorrectlyregulatoryrequirementsasappropriatetoproductdevelopmentandchangeactivitiesforassigneddevices.The candidatemusthavestrongability to interpret biological test results and detailed scientific information.

EssentialResponsibilities:

• Developtechnicallysoundprotocolsreportsandregulatorysummariesincollaborationwithcross-functionalprogramteamstestlaboratoriesandsuppliers.

• Support quality system activities including updatingprocedures and templates to ensure compliance with regulatory requirements and continuous improvement initiatives.

• Understandbiocompatibilitystrategiesthataddressgapsinmaterialsdesignandprocessestoachieveoptimalsolutionsthatsatisfycostandtechnicalrequirementsrelated tobiological safety.

• MonitorbiocompatibilitytestingactivitiestoensurethatstudiesareconductedaccordingtothestudyprotocolsSOPsapplicableregulationsandtheprinciplesofGoodLaboratoryPractices(GLP).

• Makepositivecontributionstoandrecommendapproachesforupdatinganddevelopingproceduresforinternalandexternalguidancedocumentsrelatedtobiocompatibilityin compliance with applicable global regulatory requirements (e.g.FDA ISO MHLW and CFDA).

• Assistthebiocompatibilityteammembersinidentifyingcriticalprocessfactorsandtheireffectsonbiologicalsafety.

• Supportbiologicalhazardsriskanalysisactivities.

• Interfacewithkeybusinesspartnersinternallyandexternally.

• Analyzeinterpretanddrawconclusionsfrombiocompatibilitytestingincludingbutnotlimitedtoextractableandleachablechemicalcharacterizationandbiologicalevaluations.

• Assistbiocompatibilityteammembersindevelopingstrategiesanddraftingresponsestoregulatorysubmissionquestions relatedtobiocompatibility.

Required Qualifications:

• Associates Degree(( 13 years)

• Minimum 4years experience

Preferred Qualifications

• Bachelors degree in Biomedical Engineering Molecular/Cell Biology Biochemistry Materials Science Chemistry Toxicology or other medical-related disciplines.Master in Science(MS) degree preferred.

• 3 years of industrial experience in Medical Device Pharmaceutical or Biotechnology fields withexpertisein biocompatibility toxicology and/or special process validation. A masters degree in a relevant engineering or scientific discipline may substitute for years of industry experience.

• Fundamental understanding or direct experience with ISO 10993 standards biomaterials toxicological risk assessment extractable and leachable analysis medical device manufacturing processes and biocompatibility assessmentmethodology.

• Proficient with MS Office (Word Excel Outlook PowerPoint SharePoint OneDrive).

• Strong verbal and written communication skills with the ability to effectively communicate at multiple levels within the organization.

• Strong technical writing skills with experience in writing biological risk assessments for FDA and Notified Bodies preferred.

• Ability to work within a team and as an individual contributor in a fast-paced changing environment.

• Ability to prioritize and meet deadlinesin a timely manner.

• Strong organizational and follow-up skills with attention to detail.

• Experience working in a broader enterprise/cross-division business unit model preferred.

• Ability to work in a highly matrixed and geographically diverse business environment.