安规主管岗位职责

医疗器械安规实验室主管东莞标检产品检测有限公司东莞标检产品检测有限公司,标检产品Responsibilities:

1.Workcross-functionallywithindividualsandprojectteamsinSales,Marketing,Operations,andDevelopment;

2.Createandexecutetoprojectplansandschedules

3.Providedeeptechnicalassistanceforjuniorstaff

4.Keepabreastofindustrytrendsinriskmanagement,usability,productsafety,andTrainteammembersonupdated/newregulationsastheybecomerelevantforthebusiness.

5.Performsotherrelateddutiesasassigned.

Skills:

1.BachelorDegreeinBiomedicalEngineeringandpreviousexperienceinmedicaldeviceindustry.8-10yearscurrentexperiencewithCBTLassessment,processesandprocedures.

2.Ledorparticipatedinprojectsfromdevelopmentthroughthe510(k)andCEapprovalprocess.

3.Strongbackgroundinengineeringandcommercializationofelectro-mechanicalmedicaldevices.

4.Productdesign/development(designcontrol)fromconcepttopostproductlaunchforEurope(EMEA/CEMark)&US(FDA510(k))submissions.

5.Experienceindevicedesignanddevelopment

6.ExperienceinRiskManagementdocumentreview.

7.Abilitytoread,analyze,andinterpretgeneralbusinessperiodicals,professionaljournals,technicalprocedures,orgovernmentalregulations.

8.Strongproblemsolving,riskassessment,andriskmanagementskills.

9.Mustbecapableofworkingonmultipleprojectsinadeadlinedrivenenvironment.

Familiarwiththefollowingstandards:

1.QualitySystemRegulation21CFR820

2.RiskManagementISO14971

3.EUMedicalDevicerequirementsCouncilDirective93/42/EEC

4.MedicalElectricalEquipmentEN60601