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Delhi, India Zoot Systems Full time
Zoot Systems is a New Delhi India based company. For years it has been ourcontinuous endeavours to understand Client qualityconsciousdiscerning business needs and to successfully meet those. Wespecialize in the creation of highquality I.T./NonI.T. based HRSolutions Recruitment and RPO to companies of all sizes resultingin better faster and more meaningful results. With a focus onstateoftheart

I.T. /NonI.T. services Zoot Systems developed a niche and expertise in Staffing IT Recruiting NonIT Recruiting and OffshoreOutsourcingservices .Ihave an urgent position with one of my Client; below are the JobDetails kindly take a look & let me know your comfort leveltoo.JobTitle: SR. Manager (Medical Device) RegulatoryAffairs

EmploymentType Fulltime

WorkExperience 10 Year in a similarrole

LocationDwarka (2 mints walk metrostation)Responsibilities:

EUMDR 2017Compliance:

Leadthe preparation and maintenance of technical documentationincluding the Technical File and Design Dossier according to EUMDR2017requirements.Collaboratewith teams to ensure completeness and accuracy of technicaldocumentation for product registrations and conformityassessments.Faced theaudit of the notifiedbodyUSFDARegistration:

Managethe preparation and submission of 510(k) applications IDEs(Investigational Device Exemptions) and premarket approval (PMA)submissions to theUSFDA.Providestrategic guidance on regulatory pathways for product clearance andmarket authorization in the UnitedStates.Liaise withUSFDA officials during inspections audits andcommunications.ISO 13485 QualityManagement:

Developand maintain the Quality Management System (QMS) including thepreparation of the Quality Manual and Standard Operating Procedures(SOPs) in compliance with ISO 13485requirements.Overseeinternal audits CAPA processes and training programs to ensureadherence to quality standards and regulatoryrequirements.ImplementISO 14971compliant risk management processes across theorganization.RegulatoryStrategyDevelopment:

Formulateglobal regulatory strategies for product registrations andapprovals in key markets considering EUMDR USFDA and otherapplicableregulations.Stayabreast of the evolving regulatory landscape and advise onregulatory implications for new product development projects andlifecyclemanagement.TechnicalDocumentation andSubmissions:

Leadthe preparation and maintenance of regulatory submissions technicalfiles design dossiers and other documentation required for productapprovals.Ensuretimely and accurate submission of regulatory documents toauthorities and notifiedbodies.CrossfunctionalCollaboration:

Collaborateclosely with R&D Quality Assurance Manufacturing andMarketing teams to integrate regulatory requirements into productdesign development and commercializationprocesses.Provideregulatory guidance and support throughout the product lifecyclefrom concept to postmarketsurveillance.RegulatoryIntelligence and ComplianceMonitoring:

Monitorchanges in regulations guidelines and standards affecting medicaldevices andIVDs.Assess theimpact of regulatory changes on existing products and ongoingprojects and implement compliance initiatives asnecessary.NotifiedBody and Regulatory AgencyRelations:

Buildand maintain relationships with notified bodies regulatory agenciesand industryassociations.Representthe company in regulatory interactions meetings and audits tofacilitate product approvals and regulatorycompliance.Requirements:

Bachelorsdegree in a scientific or engineering discipline; advanced degreepreferred.Minimum 7years of progressive experience in regulatory affairs within themedical deviceindustry.Indepthknowledge and experience with EUMDR 2017 USFDA regulations(including 21 CFR Part 820) and ISO 13485standards.Proventrack record of successful regulatory submissions andapprovals.Strongproject management skills with the ability to prioritize tasks andmeetdeadlines.Excellentcommunication and interpersonal skills for effectivecollaboration.Detailorientedmindset with analytical problemsolvingabilities.Experiencein developing quality manuals SOPs and technicaldocumentation.

medicaldevices,dossier preparation,mdr