ResponsibilitiesActs on behalf of Carestream Healthcare International Company Limited representing products in an assigned portfolio in assigned territoryWork closely with the Regulatory Affairs team to establish and implement corporate regulatory policies and procedures to assure compliance with applicable international regulations and standardsWork with internal regulatory resources, external distributors, and external consultants to obtain product registrations from in-country agenciesProvide guidance on Product Safety and Quality System requirements to obtain marketing approval for productsAssist in training on device regulations for medical devicesPrepare dossiers for product registrations/approvalsMaintain documentation system to assure all Carestream associates (regulatory, sales, marketing, etc.) have access to registration, license, permits, and etc. documents as required for registrations, sales and marketing supportMonitor and communicate changes to medical device products laws, standards, guidance, etc.Manage external services such as agencies and product test housesSubmit dossiers and provide Regulatory Affairs (RA) support/coordination for product registrations/approvals and ensure registrations in line with business time and cost requirementsStrongly support product registration in assigned regionAnswer questions and enquires from distributors,
dealers and customers for regulatory evidence requestsCooperate with Sales and Service; share of information onimportant customer/process issuesSupply regulatory expertise to sales managers to help support effective business plansRequirementsBachelor degree in a business, science, engineering or health related field (or other relevant discipline)A minimum of 5 years directly relevant experience in a medical device or pharmaceutical companyExperience interacting with Health Authorities is a mustFluent English and Spanish is a mustLeadership in driving Internal and external registration processes and projectsExperience in LATAM regulatory registration requirementsHave an understanding of technical products (ie. Software, Hardware, Radiology)Project management skills and communicationAbility to provide accurate advice to all levels within the companyKnowledge of repositories and IT competenceExcellent interpersonal skills and strong virtual communication skillsMust have sense of urgency, must be able to recognize and set prioritiesClose teamwork to Regulatory Affairs, Sales and Service across business unitsCore CompetenciesDemonstrates expertise in regulatory compliance for medical devices, including product registration processes and project management.
Proficient in providing regulatory guidance and support across business units while ensuring adherence to international standards.Certifications & QualificationsBachelor Degree in Business, Science, Engineering or Health Related FieldIndustry KeywordsMedical DevicePharmaceuticalRegulatory PoliciesInternational RegulationsLATAM#J-*****-Ljbffr