Director of Regulatory Affairs and Quality Assurance (RA/QA)

Job Responsibilities: Responsibilities include, but are not limited to, the following: Directs andoversees theRA/QA department. Ensureseffectivestaffing, wages, andprofessionaldevelopment. Providesleadership, supervision, anddevelopmentopportunitiestodirectreports. Verifiesperformanceofdirectreportsandmakingfairperformancedecisions. Preparestheannualdepartmentbudgetincoordinationwiththe Financedepartment. Develops, incollaboration withkeystakeholders, theglobalregulatorystrategy for RxFunction products and ensures its implementation. Identifiesapplicableregulations, standards, andguidancedocuments. Ensurescompliant, complete, andaccurateregulatory submissions toFDAand international regulatory authorities. Ensuresthatallsupportingdocumentationisproperly approvedandmaintained, whether or not a formal submission is required by FDA or another regulatory authority. ImplementsandmaintainsaneffectiveQMS, includingallrequired documentation. Ensuresproductqualitythroughout newproductdevelopment, designtransferto production, production changes, and post-production activities. Makesthefinaldecision onproductqualityholdsand releases. Ensuresthatriskmanagement evaluation andmitigationtechniques areapplied throughout product realization activities. Securesmarketapprovalsfor RxFunctionproductsintargetgeographies. Develops, incollaboration withkeystakeholders, theglobalregulatorystrategy for RxFunction products and ensures its implementation. Identifiesapplicableregulations, standards, andguidancedocuments. Ensurescompliant, complete, andaccurateregulatory submissions toFDAand international regulatory authorities. Ensuresthatallsupportingdocumentationisproperly approvedandmaintained, whether or not a formal submission is required by FDA or another regulatory authority. ImplementsandmaintainsaneffectiveQMS, includingallrequired documentation. Ensuresproductqualitythroughout newproductdevelopment, designtransferto production, production changes, and post-production activities. Makesthefinaldecision onproductqualityholdsand releases. Ensuresthatriskmanagement evaluation andmitigationtechniques areapplied throughout product realization activities. Servesasthe QualityManagement Representative. EnsuresthatprocessesneededfortheOMSaredocumentedand maintained. Reports totheleadership teamontheperformance of theOMSandanyneedfor improvement. EnsuresthepromotionofawarenessofOMS, regulatory andcustomer requirements throughout the organization. Prepares andleads Management Review meetings, which includes preparation and distributionofmaterialsregarding theOMSperformance relativetoqualityobjectives. Chairsthe Cybersecurity Panel, whichreviewsandapprovesallcybersecurity risk assessments, mitigations, and residual risk justifications and escalations. Maintainsthehighestlevelsofethicsand confidentiality. Otherdutiesandresponsibilitiesmaychangeorbeassignedatanytimewithorwithout notice.

Required Qualifications: ABachelor'sdegree inarelatedscienceorengineering discipline.15+years's experience inRegulatoryAffairsandQuality Assurance within the medical device industry, with 5+ years of supervisory experience. Extensiveknowledgeofglobalregulatoryrequirements andmarketpathways formedical devices. Demonstrated understanding of ISO13485, 21CFRPart820andother applicable FDA medical device regulations. Experiencein DesignAssurance, Operations Quality, Risk Management, Regulatory Compliance, Complaint Handling, and Regulatory Reporting to Authorities. Proventrackrecordofmanaging positive interactions withtheFDAandotherregulatory authorities with respect to inspection / audit results and obtaining market approvals. Strongleadership, verbalandwrittencommunication, andorganizational skills. Experienceworkingeffectivelywithteams withinan organization. Abilitytotravelupto 20% bycaror plane.

Preferred Qualifications: MBAorarelevantadvancedtechnical degree. ProfessionalcertificationsthroughRAPSorASQ(CMQ/OE, COE).Workingexperience withelectronicqualitymanagementsystem(eQMS) software. Advanced expertiseusingMSOfficeapplicationssuchasWord, Excel, and PowerPoint.