CVforChrisFreerJanuary2016

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CHRISTOPHERFREERBluebellMillHomeFarmBarnesTrevarnoSithneyHelstonCornwallTR130RU

Mob:+447905742810Home:+441326564836E-mail:chris.freer@chrisfreerassociates.co.ukwww.chrisfreerassociates.co.uk

PROFILEA Senior Regulatorymotivated professionalwith proven organisation, strategic and communication skills,who adopts alogical and methodical approach to problem solving, achieving tasks and objectives. With a wealth of experience andknowledgebuiltonastrongmanufacturingbackgroundintheMedicalDevicesandPharmaceuticalindustry.SPECIALTIESPre&post-marketmedicaldevicespecialist,RegulatoryStrategydevelopment,RegulatoryRequirementsandHarmonisedStandards, CE marking, QMS development, Risk Management, Design Control, Technical File & Product Design Dossierdevelopment,MDDcompliance,CAandNBLiaison,510(k),MDDCombination/BorderlineproductsandCMCintegration.CAREERSUMMARYSeptember2013-Present ChrisFreerAssociatesLtd PrincipalConsultantandManagingDirectorProviding freelance consultancy; our clients come from all backgrounds and all sizes and a wide range of differenttherapeuticareas,providingonsiteorremotesupport,whichistailoredtoourclient’srequirements.We specialise in pre & post-market medical devices, Regulatory Strategy development, Regulatory Requirements andHarmonisedStandards,CEmarking,QMSdevelopment,RiskManagement,DesignControl,TechnicalFile&ProductDesignDossier development, Own Brand Labelling Strategy (RA&QA), MDD compliance, CA and NB Liaison, 510k, MDDCombination/BorderlineproductsandCMCintegration.January2012–August2013 BiogenIdec AssociateDirector(Devices)GlobalRegulatory-CMC

AspartoftheGlobalRegulatoryCMCgroup;• Focusedonthedevelopmentofmedicaldevicesandcombinationproductsincludingauto-injectors,titrationdevice,

andsubcutaneouspumpformats• ResponsibleforactivelycontributingtothedevelopmentandimplementationofCMCdeviceregulatorystrategyfor

specificprojectsincludingidentifyingandassessingregulatoryrisks• Responsibleastheglobalsubmissionsmanager,forensuringthatthemedicaldevicesectionsofglobalsubmissionsfor

thequalitysectionsareauthored,reviewedandapprovedandareinfullregulatorycompliance• SupportglobalRegulatoryAffairs/RegulatoryComplaintswithanyfollow-upsfollowingnotifiedbody,Competent

Authority/MoHaudits• Servingastheregulatoryrepresentativeonprojectteams,servingastheregulatorycontactwithrelevantregulatory

authorities• CoordinatingdeviceCMCaspectsofregulatoryglobalsubmissionsbothpreandpostmarketapprovals• WorkingwithGovernmentandProfessionalAffairstodevelopanddeployregionalstrategicplansonfutureregulatory

areaswewanttoshapewithintheregulatoryframework• Support global Regulatory Affairs functionswith the review andmonitoring of change control requests formedical

devices• DeveloplocalprocessesandmetricsinpartnershipwiththeglobalCMCtoensure100%complaintsfromaregulatory

perspectiveformedicaldevices• ResponsibleforthecomplaintCEmarkingofmedicaldeviceintheEU,technicalfilereviewsandproductregistrations

andcompleterequiredlabellingtosupportEMEAnewproductlaunchtimelinesAchievements

• Successfulimplementationoftherequirementsofmedicaldeviceregulationsintothecompany’sglobaldirectivesandprocess

• Developmentandpresentationofmedicaldeviceandcombinationregulatorytrainingpackages• Developmentofglobalcrossfunctionallabellingprocess• ActivememberoftheTOPRAmedicaldevicespingroup• Companyrecognitionawardforworkinthecommunity

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September2008–January2012 Johnson&JohnsonVisionCare EMEARegionalRegulatoryAffairsManagerAspartoftheGlobalRegulatoryAffairsgroup;

• Responsible for ensuring prompt and successful product registration by government agencies especially in non-EUmarketsandensuresfullregulatorycomplianceacrosstheregiontosupportcurrentandfutureproductsandtoactastheEUauthorisedrepresentativeforJJVCwithassociatedresponsibilities.

• DeveloplocalprocessesandmetricsinpartnershipwithglobalRAtoensureEMEA100%complaintsfromaregulatoryperspective.

• Facilitatedesigndossier, technical file reviews andproduct registrations and complete required labelling to supportEMEAnewproductlaunchtimelines.

• WorkingwithGovernmentandProfessionalAffairstodevelopanddeployregionalstrategicplansonfutureregulatoryareaswewanttoshapewithinEMEA.

• Support global customer relations department to ensure JJVC is 100% compliantwith theMedical Device Vigilancerequirements.

• Ensure all externalmarketing communications are compliant from a regulatory perspective as part of EMEA/Globalcopyclearanceprocess.

• Voice of JJVC Regulatory Affairs (EMEA regional) at internal and external meetings; Manufacturers Associations(EucoMed,EuromcontactRA focusgroup), representingEuromcontacton theEuropeanCommissionMedicalDeviceExpertGroupforBorderlineandClassification.RepresentingJJVContheJJMD&DRACouncilfortheEMEAregion.

• Subjectmatter expert to BSiworking group; CH/172/09 Contact lenses and contact lens care products and SubjectmatterexpertrepresentingtheUKonISO/TC172/SC7/WG9.

• Regulatory consultant to markets when working on sales and/or marketing initiatives to ensure no impact ourregulatorycompliance.

• EnsurelocalmarketsharedserviceregulatoryaffairsarealignedwithJJVCregulatoryrequirementsandstrategies.• Support global Regulatory Affairs/Regulatory Complaints with any follow-ups following notified body, Competent

Authority/MoHaudits.• Support the JJVC EMEA customer supply changes QMS from a regulatory complaints perspective and interact with

notifiedbodiesandcompetentauthority/MoHrequired.• Support global Regulatory Affairs with the review and monitoring of change control requests from within all JJVC

operations.Achievements

• DevelopedonlinesystemforRAtrainingofJJVCpersonnel• SuccessfulimplementationandcertificationofQMS(ISO13485)JJVCcustomersupplychange,attheEVCfacilityfor

repackaging• LeadershipAwardforleadershipmanagementduringJJVCrecall• ReviewandimplementationinthecomplexityofIFUsforJJVCresultinginthereductionofcostandnumberofIFUs

required.• KeyMetrics(Dashboards):

§ Meetingproductregistrationtimelines§ RegulatoryComplianceIndex§ EuropeanMDVcompliancescore§ RegulatoryexternalenvironmentchangesVsgoals§ MeetingCopyClearancetimelines§ RegulatorysupportsatisfactionscorefromEMAmarkets

February2006–August2008 PharmalinkConsultingLtd. SeniorRegulatoryExecutiveWorkingforvariousbluechippharmaceuticalanddevicecompanies;

• WorkingaspartofCMCprojectteamsmanagingglobalpostapprovalregistration,variationsandsitetransfersforEUandInternationalmarkets.

• Collationofregistereddetails,CollationofMAAformattedmodule3sections,(includingthereformattinginformationfromoldParttwodossierintonewtheCTDformat)ComplianceAssessmentandremediationprojectsforEUandInternationalmarkets.

• Responsible for the preparation of high quality, detailed regulatory documentation and dossiers to support suchvariations,usingdatafromvariedinformationsources,forEUandInternationalmarkets.

• Liaising closely with other personnel to ensure the accuracy of such documentation and dossiers; and that the allproject work proceeds to agreed deadlines, working together with other functions to ensure that the projects aremanaged to established processes and guidelines. Ensuring that any potential delaying factors are highlightingpromptly,managedandthatanysuchchangesarereviewedandimplementedinatimelymanner.

• Reviewandapprovalofpackagingand labellingrequirements (EU,USA,Canadaandother internationalmarkets) forprojectsrelatingtoMedicalDeviceandDeviceCombination/Boarderlineproducts.

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• Liaising closely with Notified Bodies, MHRA, FDA and other Competent Authorities worldwide to determineappropriateregulatorystrategyforprojectsrelatingtoMedicalDeviceandDeviceCombination/Boarderlineproducts,510(k)submissions,DeviceMasterFlings,GMPandQMSinspectionsandaudits.

February2001–February2006 OwenMumfordLtd-MedicalDeviceManufacturer RegulatoryAffairsManagerAspartoftheglobalRA/QAgroup;• ResponsibleforRegulatoryAffairs,Compliance,MedicalDeviceVigilanceandpostmarketsurveillanceactivitiesofall

OwenMumfordcompanies,insupportofthecomplianceactivitiesforOwenMumford’sQualityManagementSystem(ISO13485,FDA21CFR820andotherappropriateCFR’s&GMP)throughtheusecontinualassessmentofitssystems,processesandproducts.

• PreparationofTechnicalFilesanddocumentations tosupportboth“CE”markedproductsunder theMedicalDeviceDirective, 510(k) filings for the FDA in theUSmarket andothermarkets as required forMedicalDevice andDeviceCombination/Boarderlineproducts,preparationofDeviceMasterFilings,managementofGMPinspectionsandauditsbyCompetentAuthorities.

• Supporting multi-functional project teams for new products introduction for both Owen Mumford own brandedproductsandmajorOEMPharmaceutical/Medicaldevicecompaniesworldwide.

• ReviewandapprovalofpackagingandlabellingrequirementsforOwenMunforddevicesworldwide,supportingSalesandMarketingwithappropriateregulatorycompliancestrategyforworldwidepublicationsandpromotions.

• Regular contact with Notified Bodies, Competent Authorities, MHRA, FDA and trade associations worldwide todetermineappropriateregulatorystrategyandcompliance.

May1999–January2001 ExcelTimbalex CustomerLiaisonManagerJanuary1998–March1999 HyperlastLimited SeniorQualityEngineerFebruary1988–March1990 SellerControlsLimited SeniorQualityEngineerSeptember1975–January1988 FerrantiComputerSystemsLtd EngineeringApprenticeship,various

engineeringandQC/QApositionsEducation

Examinations

OpenUniversity

ForensicEngineering;IntegratedSafety,HealthandEnvironmentalManagement(TheabovearepartofapostgraduatedegreeinManufacturing)

I.Q.A.

Measurement,StandardsandSpecificationsIntroductiontoQualityAssuranceQualityAssuranceManagementSupplierQualityAssurance

C.S.E. English,Mathematics,Chemistry,Geography,TechnicalDrawing,DesignandConstructioninWood

Courses

In-house

TOPRA–Symposium&ParalleltrackforMedicalDevices2006&2007RAPPS-IntroductiontoRegulatoryAffairs(Pharmalink)Renewals&Variations(Pharmalink)ISO10993,ISO13485&21CFR820FailureMode&EffectAnalysis(FMEA)US/EUregulatory&compliancestrategyHumanFactor/Usabilityengineering

MHRA EUMedicalDeviceVigilanceSystemDefectsinMedicalProducts(TheReporting,InvestigationandManagementofRecalls)

BritishSafetyCouncil COSHHAssessors&RiskAssessmentAuditor