RxFunction
- Eden Prairie, MN
- 2 days ago
Highlights
As the Director of Regulatory Affairs andQuality Assurance (RA/QA), this position is responsible for ensuring global leadership in RxFunction byinfluencing the creation of,and ensuring compliance with, the global regulatory requirements for the company's emerging medical device initiatives. This position willinteract with the FDA, Notified Bodies, and other regulatory authorities asneededtodeveloptheregulatory strategies andtomanageallaspects of their execution regarding RxFunction products.
Numbers & Facts
| Location | Eden Prairie, MN |
Description
PositionSummary
As the Director of Regulatory Affairs andQuality Assurance (RA/QA), this position is responsible for ensuring global leadership in RxFunction byinfluencing the creation of,and ensuring compliance with, the global regulatory requirements for the company's emerging medical device initiatives. This position willinteract with the FDA, Notified Bodies, and other regulatory authorities asneededtodeveloptheregulatory strategies andtomanageallaspects of their execution regarding RxFunction products.
This position isresponsible for ensuring theoverall effectiveness ofthe regulatory compliance program andthe quality management system (QMS) throughout theorganization, including its ongoingconformance withquality certification standards. ItreportstotheVPofTechnologyand works with all critical functions of the organization.
Job Responsibilities
Responsibilitiesinclude,but arenot limitedto,thefollowing:
Directs andoversees theRA/QA department.
• Ensureseffectivestaffing,wages,andprofessionaldevelopment.
• Providesleadership,supervision,anddevelopmentopportunitiestodirectreports.
• Verifiesperformanceofdirectreportsandmakingfairperformancedecisions.
• PreparestheannualdepartmentbudgetincoordinationwiththeFinancedepartment.
SecuresmarketapprovalsforRxFunctionproductsintargetgeographies.
• 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.
Ensuresthathigh-qualityRxFunctionproductsaredeliveredtocustomers.
• ImplementsandmaintainsaneffectiveQMS,includingallrequired documentation.
• Ensuresproductqualitythroughout newproductdevelopment, designtransferto production, production changes, and post-production activities.
• Makesthefinaldecision onproductqualityholdsandreleases.
• Ensuresthatriskmanagement evaluation andmitigationtechniques areapplied throughout product realization activities.
ServesastheQualityManagementRepresentative.
• EnsuresthatprocessesneededfortheOMSaredocumentedandmaintained.
• Reports totheleadership teamontheperformance oftheOMSandanyneedfor improvement.
• EnsuresthepromotionofawarenessofOMS,regulatory andcustomer requirements throughout the organization.
• Prepares andleads Management Review meetings, which includes preparation and distributionofmaterialsregarding theOMSperformance relativetoqualityobjectives.
ChairstheCybersecurity Panel,whichreviewsandapprovesallcybersecurity risk assessments, mitigations, and residual risk justifications and escalations.
Maintainsthehighestlevelsofethicsandconfidentiality.
Otherdutiesandresponsibilitiesmaychangeorbeassignedatany timewithorwithoutnotice.
RequiredQualifications
- ABachelor'sdegree inarelatedscienceorengineeringdiscipline.
- 15+years'experience inRegulatoryAffairsandQuality Assurance withinthemedical device industry, with 5+ years of supervisory experience.
- Extensiveknowledgeofglobalregulatoryrequirements andmarketpathways formedical devices.
- Demonstrated understanding ofISO13485, 21CFRPart820andother applicable FDA medical device regulations.
- ExperienceinDesignAssurance,OperationsQuality,RiskManagement,Regulatory Compliance, Complaint Handling, andRegulatory Reporting to Authorities.
- Proventrackrecordofmanaging positive interactions withtheFDAandotherregulatory authorities with respect to inspection / audit results and obtaining market approvals.
- Strongleadership,verbalandwrittencommunication,andorganizationalskills.
- Experienceworkingeffectivelywithteams withinanorganization.
- Abilitytotravelupto20% bycaror plane.
PreferredQualifications
- MBAorarelevantadvancedtechnicaldegree.
- ProfessionalcertificationsthroughRAPSorASQ(CMQ/OE,COE).
- Workingexperience withelectronicqualitymanagementsystem(eQMS)software.
- Advanced expertiseusingMSOfficeapplicationssuchasWord,Excel,andPowerPoint.
PhysicalRequirements:
• Thephysicaldemandsdescribed withintheResponsibilitiessectionofthisjobdescription arerepresentativeofthose that must bemet by anemployee tosuccessfully perform the essential functions of this job. Reasonable accommodationsmay be made toenable individuals with disabilities to perform the essential functions.
• Whileperforming thedutiesofthisjob,theemployee isregularly requiredtobe independently mobile. The employee is also required touse acomputer and communicatewith others.